Document and Entity Information
Document and Entity Information - shares | 3 Months Ended | |
Mar. 31, 2020 | May 04, 2020 | |
Cover [Abstract] | ||
Document Type | 10-Q | |
Amendment Flag | false | |
Document Period End Date | Mar. 31, 2020 | |
Document Fiscal Year Focus | 2020 | |
Document Fiscal Period Focus | Q1 | |
Entity Registrant Name | Savara Inc. | |
Entity Central Index Key | 0001160308 | |
Entity Interactive Data Current | Yes | |
Trading Symbol | SVRA | |
Current Fiscal Year End Date | --12-31 | |
Entity Filer Category | Accelerated Filer | |
Entity Small Business | true | |
Entity Emerging Growth Company | false | |
Entity Common Stock, Shares Outstanding | 52,187,063 | |
Entity Current Reporting Status | Yes | |
Entity Shell Company | false | |
Entity File Number | 001-32157 | |
Entity Tax Identification Number | 84-1318182 | |
Entity Address, Address Line One | 6836 Bee Cave Road | |
Entity Address, Address Line Two | Building III | |
Entity Address, Address Line Three | Suite 200 | |
Entity Address, City or Town | Austin | |
Entity Address, State or Province | TX | |
Entity Address, Postal Zip Code | 78746 | |
City Area Code | 512 | |
Local Phone Number | 614-1848 | |
Document Quarterly Report | true | |
Document Transition Report | false | |
Entity Incorporation, State or Country Code | DE | |
Title of 12(b) Security | Common Stock, par value $0.001 per share | |
Security Exchange Name | NASDAQ |
Condensed Consolidated Balance
Condensed Consolidated Balance Sheets (Unaudited) - USD ($) $ in Thousands | Mar. 31, 2020 | Dec. 31, 2019 |
Current assets: | ||
Cash and cash equivalents | $ 34,515 | $ 49,804 |
Short-term investments | 70,472 | 71,957 |
Prepaid expenses and other current assets | 2,458 | 2,306 |
Total current assets | 107,445 | 124,067 |
Property and equipment, net | 294 | 352 |
In-process R&D | 10,930 | 11,111 |
Other non-current assets | 1,306 | 673 |
Total assets | 119,975 | 136,203 |
Current liabilities: | ||
Accounts payable | 1,227 | 3,409 |
Accrued expenses and other current liabilities | 6,502 | 5,471 |
Debt facility | 2,000 | |
Total current liabilities | 7,729 | 10,880 |
Long-term liabilities: | ||
Debt facility | 24,731 | 23,112 |
Other long-term liabilities | 199 | 513 |
Total liabilities | 32,659 | 34,505 |
Stockholders’ equity: | ||
Common stock, $0.001 par value, 200,000,000 shares authorized as of March 31, 2020 and December 31, 2019; 50,844,504 and 50,790,441 shares issued and outstanding as of March 31, 2020 and December 31, 2019, respectively | 52 | 52 |
Additional paid-in capital | 310,705 | 309,555 |
Accumulated other comprehensive loss | (128) | (17) |
Accumulated deficit | (223,313) | (207,892) |
Total stockholders’ equity | 87,316 | 101,698 |
Total liabilities and stockholders’ equity | $ 119,975 | $ 136,203 |
Condensed Consolidated Balanc_2
Condensed Consolidated Balance Sheets (Unaudited) (Parenthetical) - $ / shares | Mar. 31, 2020 | Dec. 31, 2019 |
Statement Of Financial Position [Abstract] | ||
Common stock, par value | $ 0.001 | $ 0.001 |
Common stock, shares authorized | 200,000,000 | 200,000,000 |
Common stock, shares issued | 50,844,504 | 50,790,441 |
Common stock, shares outstanding | 50,844,504 | 50,790,441 |
Condensed Consolidated Statemen
Condensed Consolidated Statements of Operations and Comprehensive Loss (Unaudited) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2020 | Mar. 31, 2019 | |
Operating expenses: | ||
Research and development | $ 13,200 | $ 10,019 |
General and administrative | 2,982 | 2,763 |
Depreciation and amortization | 58 | 138 |
Total operating expenses | 16,240 | 12,920 |
Loss from operations | (16,240) | (12,920) |
Other income, net: | ||
Interest expense, net | (160) | (20) |
Foreign currency exchange gain (loss) | 156 | (59) |
Tax credit income | 821 | 964 |
Change in fair value of financial instruments | 2 | (77) |
Total other income | 819 | 808 |
Loss before income taxes | (15,421) | (12,112) |
Net loss | $ (15,421) | $ (12,112) |
Net loss per share: | ||
Basic and diluted | $ (0.27) | $ (0.34) |
Weighted average common shares outstanding: | ||
Basic and diluted | 57,364,265 | 36,016,406 |
Other comprehensive loss: | ||
Loss on foreign currency translation | $ (128) | $ (225) |
Unrealized gain on short-term investments | 17 | 26 |
Total comprehensive loss | $ (15,532) | $ (12,311) |
Consolidated Statements of Chan
Consolidated Statements of Changes in Stockholders' Equity (Unaudited) - USD ($) $ in Thousands | Total | Common Stock [Member] | Additional Paid-in Capital [Member] | Accumulated Deficit [Member] | Accumulated Other Comprehensive Income (Loss) [Member] |
Beginning balances at Dec. 31, 2018 | $ 108,219 | $ 36 | $ 237,702 | $ (129,719) | $ 200 |
Beginning balance, shares at Dec. 31, 2018 | 35,146,096 | ||||
Issuance of common stock upon at the market offerings, net | 4,890 | 4,890 | |||
Issuance of common stock upon at The market offering, net, shares | 647,426 | ||||
Issuance of common stock for settlement of RSUs, shares | 13,125 | ||||
Issuance of common stock upon exercise of stock options | 6 | 6 | |||
Issuance of common stock upon exercise of stock options, shares | 23,593 | ||||
Stock-based compensation | 1,000 | 1,000 | |||
Foreign exchange translation adjustment | (225) | (225) | |||
Unrealized gain on short-term investments | 26 | 26 | |||
Net loss incurred | (12,112) | (12,112) | |||
Ending balance at Mar. 31, 2019 | 101,804 | $ 36 | 243,598 | (141,831) | 1 |
Ending balance, shares at Mar. 31, 2019 | 35,830,240 | ||||
Beginning balances at Dec. 31, 2019 | 101,698 | $ 52 | 309,555 | (207,892) | (17) |
Beginning balance, shares at Dec. 31, 2019 | 50,790,441 | ||||
Issuance of common stock for settlement of RSUs, shares | 12,750 | ||||
Issuance of common stock upon exercise of stock options | 48 | 48 | |||
Issuance of common stock upon exercise of stock options, shares | 41,313 | ||||
Closing costs for previous issuance of securities in private placement | (120) | (120) | |||
Incremental cost due to modification of detachable warrants previously issued with debt instrument | 28 | 28 | |||
Stock-based compensation | 1,194 | 1,194 | |||
Foreign exchange translation adjustment | (128) | (128) | |||
Unrealized gain on short-term investments | 17 | 17 | |||
Net loss incurred | (15,421) | (15,421) | |||
Ending balance at Mar. 31, 2020 | $ 87,316 | $ 52 | $ 310,705 | $ (223,313) | $ (128) |
Ending balance, shares at Mar. 31, 2020 | 50,844,504 |
Condensed Consolidated Statem_2
Condensed Consolidated Statements of Cash Flows (Unaudited) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2020 | Mar. 31, 2019 | |
Cash flows from operating activities: | ||
Net loss | $ (15,421) | $ (12,112) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Depreciation and amortization including right-of-use assets | 242 | 307 |
Acquired in-process research and development (Note 7) | 5,367 | |
Changes in fair value of financial instruments | (2) | 77 |
Change in fair value of contingent consideration | 133 | |
Noncash interest (income) expense | 133 | (4) |
Foreign currency (gain) loss | (156) | 59 |
Amortization of debt issuance costs | 134 | 147 |
Accretion on discount to short-term investments | (69) | (342) |
Stock-based compensation | 1,194 | 1,000 |
Changes in operating assets and liabilities: | ||
Prepaid expenses and other current assets | (195) | 69 |
Non-current assets | (821) | (953) |
Accounts payable and accrued expenses and other current liabilities | (3,180) | 953 |
Long-term liabilities | (305) | (193) |
Net cash used in operating activities | (13,079) | (10,859) |
Cash flows from investing activities: | ||
Purchase of property and equipment | (4) | (96) |
Purchase in-process research and development (Note 7) | (3,247) | |
Purchase of available-for-sale securities, net | (35,614) | (46,035) |
Maturities of available-for-sale securities | 31,300 | 42,800 |
Sale of available-for-sale securities, net | 5,780 | 10,651 |
Net cash (used in) provided by investing activities | (1,785) | 7,320 |
Cash flows from financing activities: | ||
Issuance of common stock upon at the market offerings, net | 4,890 | |
Repayment of debt facility | (514) | |
Proceeds from exercise of stock options | 48 | 6 |
Net cash (used in) provided by financing activities | (466) | 4,896 |
Effect of exchange rate changes on cash and cash equivalents | 41 | 13 |
Increase (decrease) in cash and cash equivalents | (15,289) | 1,370 |
Cash and cash equivalents beginning of period | 49,804 | 24,301 |
Cash and cash equivalents end of period | 34,515 | 25,671 |
Non-cash transactions | ||
Acquisition of in-process research and development (Note 7) | (2,120) | |
Supplemental disclosure of cash flow information: | ||
Cash paid for interest and end of period charge due upon debt facility amendment | $ 990 | $ 528 |
Description of Business and Bas
Description of Business and Basis of Presentation | 3 Months Ended |
Mar. 31, 2020 | |
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. (together with its subsidiaries “Savara,” the “Company,” “we” or “us”) is an orphan lung disease company with a pipeline that comprises three investigational compounds, all of which use an inhaled delivery route. The Company’s lead program, Molgradex, 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 interim condensed 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”). These condensed consolidated financial statements should be read in conjunction with the audited financial statements and notes thereto for the year ended December 31, 2019. Certain prior period amounts have been reclassified for consistency with current period presentation. Unaudited Interim Financial Information The interim condensed consolidated financial statements included in this document are unaudited. The unaudited interim financial statements have been prepared on the same basis as the annual financial statements and reflect, in the opinion of management, all adjustments of a normal and recurring nature that are necessary for a fair statement of the Company’s financial position as of March 31, 2020, and its results of operations for the three months ended March 31, 2020 and 2019, and cash flows for the three months ended March 31, 2020 and 2019. The results of operations for interim periods shown in this report are not necessarily indicative of the results to be expected for the year ending December 31, 2020 or for any other future annual or interim period. The December 31, 2019 consolidated balance sheet was derived from audited financial statements but does not include all disclosures required by U.S. GAAP. These condensed consolidated financial statements should be read in conjunction with the audited financial statements and notes thereto for the year ended December 31, 2019. |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 3 Months Ended |
Mar. 31, 2020 | |
Accounting Policies [Abstract] | |
Summary of Significant Accounting Policies | 2. Summary of Significant Accounting Policies Liquidity As of March 31, 2020, the Company had an accumulated deficit of approximately $223.3 million. The Company also had negative cash flow from operations of approximately $13.1 million during the three months ended March 31, 2020. 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. Currently, the Company is primarily focused 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 is also continuously and critically reviewing our liquidity and anticipated capital requirements in light of the uncertainty resulting from the COVID-19 global pandemic. While the Company had cash and cash equivalents of $34.5 million and short-term investments of $70.5 million as of March 31, 2020, the Company intends to continue to raise additional capital as needed through the issuance of additional equity securities 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 condensed consolidated financial statements do not include any adjustments that might result from the outcome of this uncertainty. Principles of Consolidation The interim condensed 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 (loss).” 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 and general and administrative costs, certain financial instruments recorded at fair value, contingent consideration, 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. Short-term Investments The Company has classified its investments in debt 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 reflected as a part of “Accumulated other comprehensive income 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 or expensed 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. To date, 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 available information and, in some cases, assumptions with respect to the timing and amount of future revenue and expenses associated with an asset. License and Collaboration Agreements The Company enters into license and collaboration agreements with third parties whereby the Company purchases the rights to develop, market, sell and/or distribute the underlying pharmaceutical products or drug candidates. Pursuant to these agreements, the Company is generally required to make up-front payments, milestone payments contingent upon the achievement of certain pre-determined criteria, royalty payments based on specified sales levels of the underlying products and/or certain other payments. Up-front payments are either expensed immediately as research and development or capitalized. The determination to capitalize amounts related to licenses is based on management’s judgments with respect to stage of development, the nature of the rights acquired, alternative future uses, developmental and regulatory issues and challenges, the net realizable value of such amounts based on projected sales of the underlying products, the commercial status of the underlying products, and/or various other competitive factors. Milestone payments made prior to regulatory approval are generally expensed as incurred and milestone payments made subsequent to regulatory approval are generally capitalized as an intangible asset. Royalty payments are expensed as incurred. Other payments made pursuant to license and collaboration agreements, which are generally related to research and development activities, are expensed as incurred. Goodwill, Acquired In-Process Research and Development, and Deferred Tax Liability Although the Company does not have any goodwill as of March 31, 2020, it has adopted the following accounting policy. Goodwill represents the excess of purchase price over the fair value of net assets acquired by the Company. Goodwill is not amortized but assessed for impairment on an annual basis or more frequently if impairment indicators exist. Current guidance issued by the FASB, as previously adopted by the Company, provides an impairment model whereby the Company has the option to implement a one-step method for determining impairment of goodwill, simplifying the subsequent measurement of goodwill by eliminating Step 2 (quantitative calculation of measuring a goodwill impairment loss by comparing the implied fair value of a reporting unit’s goodwill with the carrying amount of that goodwill) from the goodwill impairment test. Under the amendments in this guidance, an entity should perform its annual goodwill impairment test by comparing the fair value of a reporting unit with its carrying amount. An entity should recognize an impairment charge for the amount by which the carrying amount exceeds the reporting unit’s fair value; however, the loss recognized should not exceed the total amount of goodwill allocated to that reporting unit. Additionally, an entity should consider income tax effects from any tax-deductible goodwill on the carrying amount of the reporting unit when measuring the goodwill impairment loss, if applicable. Acquired in-process research and development (“IPR&D”) is considered an indefinite-lived intangible asset and is assessed for impairment annually or more frequently if impairment indicators exist. For instance, based upon the ultimate scope and scale of the COVID - 19 global pandemic, there may be materially negative impacts to the assumptions made with respect to our IPR&D assets that could result in an impairment of such assets. For the three months ended March 31, 2020, the impact of COVID-19 did not trigger any impairment indicators. The Company adopted accounting guidance related to its annual acquired IPR&D impairment test, a two-step method, 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 IPR&D is more likely than not less than the carrying amount, a quantitative impairment test is required. If the associated research and development effort is abandoned, the related asset will be written-off, and the Company will record a noncash impairment loss on its consolidated statements of operations and comprehensive loss. For those products that reach commercialization, the IPR&D asset will be amortized over its estimated useful life. The Company performs its annual goodwill impairment test and IPR&D impairment test, as described above, as of June 30th and September 30th, respectively, or whenever an event or change in circumstances occurs that would require reassessment of the recoverability of those assets. For the three months ended March 31, 2020, the Company experienced a decrease of approximately $0.2 million in the carrying value of IPR&D, which was due to foreign currency translation. Tax Credit Receivable The Company has recorded a Danish tax credit earned by its subsidiary, Savara ApS, as of March 31, 2020. 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. As of March 31, 2020, credits totaling $1.6 million had been generated but not yet received. Of this total Danish tax credit, $0.8 million is related to research and development activities incurred during the year ended December 31, 2019 and is recorded in “Prepaid expenses and other current assets” and expected to be received in the fourth quarter of 2020. The remaining portion of the Danish tax credit of $0.8 million, which was generated during the three months ended March 31, 2020, is recorded in “Other non-current assets” and is expected to be received in the fourth quarter of 2021. The Company also recognized tax credit income for the three months ended March 31, 2020 as provided by the Australian Taxation Office for qualified research and development expenditures incurred through our subsidiary, Savara Australia Pty. Limited. Under Australian tax law, Australia remits a research and development tax credit equal to 43.5% of qualified research and development expenditures, not to exceed established thresholds. As of March 31, 2020, credits totaling $0.5 million had been generated but not yet received. Of this total Australian tax credit, $0.4 million is related to research and development activities incurred during the year ended December 31, 2019 and is recorded in “Prepaid expenses and other current assets” and expected to be received during the year ending December 31, 2020. The remaining portion of the Australian tax credit of $0.1 million, which was generated during the three months ended March 31, 2020, is recorded in “Other non-current assets” and is expected to be received during the year ended December 31, 2021. Leases In February 2016, the FASB issued Accounting Standards Update (“ASU”) 2016-02, “Leases (Topic 842)” (“ASU 2016-02”) as codified in Accounting Standards Codification (“ASC”) 842 (“ASC 842”). ASU 2016-02, ASC 842, and additional issued guidance are intended to improve financial reporting of leasing transactions by requiring organizations that lease assets to recognize assets and liabilities for the rights and obligations created by leases that extend more than twelve months. This accounting update also requires additional disclosures surrounding the amount, timing, and uncertainty of cash flows arising from leases. ASU 2016-02 is effective for financial statements issued for annual and interim periods beginning after December 15, 2018 for public business entities. The Company adopted ASU 2016-02 as of January 1, 2019 using the effective date transition method of implementation offered under ASU 2018-11, “Leases (Topic 842) – Targeted Improvements” issued in July 2018 (“ASU 2018-11”), under which entities may change their date of initial application of ASU 2016-02 to the beginning of the period of adoption, or January 1, 2019, in the case of Savara. Accordingly, the Company is required to apply the prior lease guidance pursuant to ASC Topic 840 in the comparative periods, provide the disclosures required by ASC Topic 840 for all periods that continue to be presented in accordance with ASC Topic 840, recognize the effects of applying ASC 842 as a cumulative-effect adjustment to retained earnings as of January 1, 2019, if any, and provide certain disclosures under ASC 842 (see Note 11). The Company has also elected the package of practical expedients, applied by class of underlying asset, permitted in ASU 2018-11. Accordingly, the Company accounted for its existing operating leases as operating leases under the new guidance, without reassessing (a) whether the contracts contain a lease under ASC 842, (b) whether classification of the operating leases would be different in accordance with ASC 842, and (c) whether the unamortized initial direct costs before transition adjustments (as of the period of adoption) would have met the definition of initial direct costs in ASC 842 at lease commencement, and the Company did not separate lease and non-lease components. As a result of the adoption of the new lease accounting guidance using the effective date transition method, on January 1, 2019, the Company recognized (a) a lease liability of approximately $1.4 million, which represents the present value of the remaining lease payments, as of the date of adoption, of approximately $1.5 million, discounted using the Company’s incremental borrowing rate of 8.5%, and (b) a right-of-use asset of approximately $1.4 million. The adoption of the new standard did not result in any adjustment to the Company’s retained earnings as of January 1, 2019. The adoption of this standard did not have a material impact on the Company’s condensed consolidated balance sheets, cash used/provided from operating, investing, or financing activities in the condensed consolidated statements of cash flows, or on the Company’s operating results. The most significant impact was the recognition of right-of-use assets for operating leases, which are reflected in “Other non-current assets,” and lease liabilities for operating leases, which are reflected in “Accrued expenses and other current liabilities,” for the current portion of the lease liabilities, and in “Other long-term liabilities” for the non-current portion of the lease liabilities, respectively (See Note 11). 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, short-term investments, and foreign exchange derivatives not designated as hedging instruments. 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. Revenue Recognition The Company will record revenue based on a five-step model in accordance with ASC 606, “Revenue from Contracts with Customers.” To date, the Company has not generated any product revenue from its drug candidates. The Company’s ability to generate product revenues, which the Company does not expect will occur in the near term, if ever, will depend heavily on the successful development, regulatory approval, and eventual commercialization of the Company’s product candidates. Milestone Revenue The Company is subject to a license agreement related to its Molgradex product candidate, which includes certain milestone payments to be remunerated by the licensee to Savara. In exchange, the Company granted the licensee an exclusive right to import, market, sell, distribute and promote Molgradex in Japan for the treatment of aPAP. Pursuant to the license agreement, the Company identifies the performance obligations, determines the transaction price, allocates the contract transaction price to the performance obligations, and recognizes the revenue when (or as) the performance obligation is satisfied. The Company identifies the performance obligations included within the license agreement and evaluates which performance obligations are distinct. The milestone payments are a form of variable consideration as the payments are contingent upon achievement of a substantive event. The milestone payments are estimated and included in the transaction price when the Company determines, under the variable consideration constraint, that it is probable that there will not be a significant reversal of cumulative revenue recognized in future periods. The transaction price is then allocated to each performance obligation on a relative stand-alone selling price basis, for which the Company recognizes revenue as or when the performance obligations under the contract are satisfied. At the end of each subsequent reporting period, the Company re-evaluates the probability of achievement of such milestones and any related constraint, and if necessary, adjusts the estimate of the overall transaction price. In October 2018, the Company achieved a milestone payment pursuant to this license agreement resulting in the receipt of $0.3 million from the licensee. As of March 31, 2020, the Company has determined that it has not met all of the performance obligations under this license agreement and, accordingly, has recorded the milestone payment as deferred revenue in “Accrued expenses and other current liabilities” in the Company’s condensed consolidated balance sheet until such time the performance obligations are met. On February 21, 2020, the Company received notification from the licensee of its intent to terminate this license agreement. Accordingly, this license agreement shall terminate on August 21, 2020 upon which the Company shall recognize revenue related to this $0.3 million milestone payment. Net Loss per Share Basic net loss attributable to common stockholders per share is calculated by dividing the net loss attributable to common stockholders by the weighted average number of shares of common stock and pre-funded warrants 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. 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 12). Forfeitures are recognized when they occur, which may result in the reversal of compensation costs in subsequent periods as the forfeitures arise. Manufacturing, Development, and Other Commitments and Contingencies The Company is subject to various royalties and manufacturing and development payments related to its product candidates, Molgradex and Apulmiq. Under a manufacture and supply agreement with the active pharmaceutical ingredients (“API”) manufacturer for Molgradex, Savara must make certain payments to the API manufacturer upon achievement of the milestones outlined in the table set forth below. Additionally, upon first receipt of marketing approval by Savara from a regulatory authority in a country for a product containing the API for therapeutic use in humans and ending the earlier of (i) ten (10) years thereafter or (ii) the date a biosimilar of such product is first sold in such country, Savara shall pay the API manufacturer a royalty equal to low-single digits of the net sales in that country. Under a license and collaboration agreement for the rights to develop and commercialize Apulmiq, the Company is subject to certain contingent development payments and contingent sales payments due to the licensor upon the achievement of certain milestones up to amounts as set forth in the following table (see Note 7). The Company will also owe the licensor low double-digit tiered royalties based on annual global net sales of licensed products (on a product-by-product basis), which are subject to reduction if another inhaled ciprofloxacin product is introduced into the market. Under an agreement with a medical education and research foundation entered into on October 8, 2018, the Company is subject to a milestone payment for the use of proprietary information and material in intellectual property filings related to the application of Molgradex in the treatment of NTM. The Company will owe royalties to the foundation based on net sales of Molgradex for the treatment of NTM equal to one half of one percent (0.5%) after publication of the intellectual property filings and one quarter of one percent (0.25%) prior to the publication or in the event publication does not occur, with respect to the specified intellectual property filings. The Company is also subject to certain contingent milestone payments, disclosed in the following table, payable to the manufacturer of the nebulizer used to administer Molgradex. The change in the amount of the milestone payments from December 31, 2019 to March 31, 2020 was related to Manufacturing, Development, and Other Contingent Milestone Payments (in thousands): March 31, 2020 Molgradex API manufacturer: Achievement of certain milestones related to validation of API and regulatory approval of Molgradex $ 2,300 Molgradex nebulizer manufacturer: Achievement of various development activities and regulatory approval of nebulizer utilized to administer Molgradex 7,331 Medical education and research foundation (Molgradex): First commercial sale in the U.S. of Molgradex in treatment of NTM 500 Apulmiq Licensor: Achievement of various development activities and regulatory approval of Apulmiq for the treatment of NCFB 50,000 Achievement of various sales activities of Apulmiq for treatment of NCFB 100,000 Total manufacturing and other commitments $ 160,131 The milestone commitments disclosed above reflect the activities that have (i) not been met or incurred; (ii) not been remunerated; and (iii) not accrued, as the activities are not deemed probable or reasonably estimable, as of March 31, 2020. 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 February 2020, the FASB issued ASU 2020-02, “Financial Instruments—Credit Losses (Topic 326) and Leases (Topic 842)—Amendments to SEC Paragraphs Pursuant to SEC Staff Accounting Bulletin No. 119 and Update to SEC Section on Effective Date Related to Accounting Standards Update 2016-02, Leases (Topic 842) (SEC Update).” The company has reviewed ASU 2020-02 and concluded that it does not have a material impact on our condensed consolidated financial statements. In March 2020, the FASB issued ASU 2020-03, “Codification Improvements to Financial Instruments,” which addressed various issues including the following: (i) clarification that all entities are required to provide the (“ASU 2020-03”) fair value option disclosures in paragraphs 825-10-50-24 through 50-32 of the FASB’s ASC, (ii) clarification that the contractual term of a net investment in a lease determined in accordance with ASC 842, “Leases,” should be the contractual term used to measure expected credit losses under ASC 326, “Financial Instruments – Credit Losses,” and (iii) amendment of ASC 860-20, “Transfers and Servicing – Sales of Financial Assets,” clarifying that when an entity regains control of financial assets sold, an allowance for credit losses should be recorded in accordance with ASC 326. The Company has reviewed ASU 2020-3 and concluded that it does not have a material impact on our condensed consolidated financial statements. In March 2020, the FASB issued ASU 2020-04, “Reference Rate Reform (Topic 848)” which provides optional guidance for a limited period of time to ease the potential burden in accounting for the effects of the transition away from LIBOR and other reference rates.” The company has reviewed ASU 2020-04 and concluded that it has no impact on our condensed consolidated financial statements. |
Prepaid Expenses and Other Curr
Prepaid Expenses and Other Current Assets | 3 Months Ended |
Mar. 31, 2020 | |
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): March 31, 2020 December 31, 2019 R&D tax credit receivable $ 1,233 $ 1,253 Prepaid contracted research and development costs 422 184 VAT receivable 356 364 Prepaid insurance 86 247 Foreign currency exchange derivative — 7 Deposits and other 361 251 Total prepaid expenses and other current assets $ 2,458 $ 2,306 |
Accrued Expenses and Other Curr
Accrued Expenses and Other Current Liabilities | 3 Months Ended |
Mar. 31, 2020 | |
Payables And Accruals [Abstract] | |
Accrued Expenses and Other Current Liabilities | 4. Accrued expenses and other current liabilities Accrued expenses and other current liabilities consisted of (in thousands): March 31, 2020 December 31, 2019 Accrued contracted research and development costs $ 2,100 $ 2,018 Accrued general and administrative costs 820 1,710 Accrued closing costs for previous issuance of securities in private placement 120 — Accrued compensation 705 1,303 Foreign currency exchange derivative 88 — Deferred revenue 238 — Common stock due for in-licensing of development and commercialization rights 2,120 — Lease liability 311 440 Total accrued expenses and other current liabilities $ 6,502 $ 5,471 |
Short-term Investments
Short-term Investments | 3 Months Ended |
Mar. 31, 2020 | |
Investments Debt And Equity Securities [Abstract] | |
Short-term Investments | 5. Short-term Investments 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 (in thousands): As of March 31, 2020 Amortized Cost Gross Unrealized Gains Gross Unrealized Losses Fair Value Short-term investments U.S. government securities $ 15,624 $ 121 $ — $ 15,745 Asset backed securities 3,027 — — 3,027 Corporate securities 25,395 6 (62 ) 25,339 Commercial paper 26,361 — — 26,361 Total short-term investments $ 70,407 $ 127 $ (62 ) $ 70,472 As of December 31, 2019 Amortized Cost Gross Unrealized Gains Gross Unrealized Losses Fair Value Short-term investments U.S. government securities $ 15,629 $ 11 $ (2 ) $ 15,638 Asset backed securities 8,789 10 — 8,799 Corporate securities 30,556 30 (1 ) 30,585 Commercial paper 16,935 — — 16,935 Total short-term investments $ 71,909 $ 51 $ (3 ) $ 71,957 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 reflected as a part of “Accumulated other comprehensive income (loss)” in the condensed consolidated balance sheets. Classification as short-term or long-term is based upon whether the maturity of the debt securities is less than or greater than twelve months. There were no significant realized gains or losses related to investments for the three months ended March 31, 2020 and March 31, 2019. |
Debt Facility
Debt Facility | 3 Months Ended |
Mar. 31, 2020 | |
Debt Disclosure [Abstract] | |
Debt Facility | 6. Debt Facility On April 28, 2017, the Company entered into a loan and security agreement with Silicon Valley Bank, as amended on October 31, 2017 and December 4, 2018 (the “Loan Agreement”). The Company executed a third amendment (the “Third Amendment”) to the Loan Agreement on January 31, 2020, which provides for a $25 million term debt facility. The Third Amendment extends the interest-only period of the loan repayment through June 30, 2022, with payments thereafter in equal monthly installments of principal plus interest over 18 months. However, if by March 31, 2021, the Company does not have an ongoing Phase 3 or Phase 4 clinical trial evaluating its Molgradex product for the treatment of aPAP in which the first patient has been dosed, the interest-only period will end and principal plus interest will be due in equal monthly installments over 24 months beginning on April 1, 2021. Following the effective date of the Third Amendment, the Company was required to pay a portion of the end of period charge equal to $0.5 million under the Loan Agreement to Silicon Valley Bank. The loans bear interest at the greater of (i) the prime rate reported in The Wall Street Journal, plus a spread of 3.0% or (ii) 7.75%. The Loan Agreement, as amended by the Third Amendment (the “Amended Loan Agreement”) will also require a prepayment fee (2.0% of funded amounts in months 13-24, and 1.0% thereafter), and an end of term charge equal to 6.0% of the amount of principal borrowed. 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 Amended Loan Agreement contains customary affirmative and negative covenants, including among others, covenants limiting our ability and our subsidiaries’ ability 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. In addition, the Amended Loan Agreement contains an affirmative covenant requiring Savara to deliver evidence by June 30, 2021, of the receipt of gross cash proceeds of at least $25 million from the exercise of currently outstanding warrants or the issuance of other equity securities. Pursuant to the execution and funding of the Loan Agreement and subsequent amendments, the Company issued Silicon Valley Bank and its affiliate warrants to purchase (i) 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”); (ii) 41,736 shares of the Company’s common stock at an exercise price of $5.39 per share with a ten-year life, expiring June 15, 2027 (“June 2017 Warrants”); and (iii) 11,332 shares of the Company’s common stock at an exercise price of $8.824 per share, with a ten-year life, expiring December 4, 2028 (“December 2018 Warrants”). The warrants were valued using the Black-Scholes-Merton option pricing model at the respective issue date, and the collective fair value of the warrants has been recorded as a debt discount which is being amortized through interest expense using the effective interest method through the scheduled maturity date. In connection with the execution of the Third Amendment, the Company entered into amendments to each of the outstanding warrants previously issued to Silicon Valley Bank and its affiliate, totaling 77,793 shares, to amend the exercise price to be $2.87 per share. That amendment results in a minimal incremental increase to the fair value of these warrants, determined in accordance with the Black-Scholes-Merton option pricing model and ASC 718-20-55, which has been recognized as interest expense. The Company paid minimal legal costs directly attributable to the original issuance of the debt instrument underlying the Loan Agreement and subsequent amendments. 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. The Company has analyzed the Third Loan Amendment and concluded that the debt restructuring results in modification accounting under ASC 470 “Simplifying the Classification of Debt in a Classified Balance Sheet (Current versus Noncurrent).” Summary of Carrying Value The following table summarizes the components of the debt facility carrying value, which approximates the fair value (in thousands): As of March 31, 2020 Short-term Long-term Principal payments to lender and end of term charge $ — $ 25,064 Debt Issuance costs $ (189 ) Debt discount related to warrants — (144 ) Carrying Value $ — $ 24,731 The carrying value of the debt facility approximates fair value. |
Apulmiq License Agreement
Apulmiq License Agreement | 3 Months Ended |
Mar. 31, 2020 | |
Organization Consolidation And Presentation Of Financial Statements [Abstract] | |
Apulmiq License Agreement | 7. Apulmiq License Agreement On January 7, 2020, the Company entered into a license and collaboration agreement with Grifols, S.A., a company organized under the laws of Spain (“Grifols”), which was subsequently amended on February 18, 2020 and March 31, 2020 (the “License”). On March 31, 2020, the final condition precedent to the effectiveness of the License was satisfied, and the License became effective. The License provides Savara with an exclusive, worldwide, royalty-bearing license, with rights to sublicense, patent rights owned or controlled by Grifols (the “Grifols Patents”) and know-how owned or controlled by Grifols to make, have made, use, develop, import and export, supply, offer for sale, and sell or otherwise commercialize pharmaceutical preparations containing ciprofloxacin in a liposomal formulation and/or ciprofloxacin that is not encapsulated in liposomes (each such pharmaceutical preparation a “Licensed Product”) for all uses. Under the License, the Company has sole responsibility for the activities and costs related to the development of (1) a Licensed Product for the treatment of either NCFB The Company agreed to pay Grifols (i) an upfront cash payment of approximately $3.3 million and (ii) an upfront payment of one million shares of the Company’s common stock valued at approximately $2.1 million on the date of issuance (the “Consideration Shares”) upon effectiveness of the License, (collectively the “Upfront Payments”). The Company also agreed to pay Grifols (i) certain developmental milestone payments totaling up to $50 million for the development of the Licensed Products for the treatment of NCFB upon approval of a Licensed Product for commercial sale by the FDA and EMA and (ii) certain sales milestone payments totaling up to $100 million upon the first achievement of annual global net sales of (a) $100 million, (b) $300 million, and (c) $500 million (collectively, the “Contingent Consideration”). Additionally, the Company agreed to pay Grifols low double-digit tiered royalties based on annual global net sales of all Licensed Products, which are subject to reduction if another inhaled ciprofloxacin product is introduced into the market. The Company is obligated to make such royalty payments on a country-by-country and Licensed Product-by-Licensed Product basis until the later of (i) ten (10) years after the first commercial sale of a Licensed Product in a country, (ii) expiration of the last Grifols Patent covering that Licensed Product in that country, or (iii) the date a generic inhaled liposomal ciprofloxacin is introduced in that country (the “Royalty Term”). At the end of the Royalty Term, the Company will have a fully paid-up license for the applicable Licensed Product. The Company has accounted for the License as an asset acquisition in accordance with ASU 2017-01 “Business Combinations (Topic 805) - Clarifying the Definition of a Business” and ASC 805 “Business Combinations.” Since the Licensed Product has not yet achieved regulatory approval and there is deemed to be no alternative future use, the Company has recorded research and development expense of approximately $5.4 million for the Upfront Payments. The Company has determined that the Contingent Consideration is currently neither probable nor can the amount be reasonably estimated, and therefore, no related liability has been recorded as of March 31, 2020. The term of the License continues until the Royalty Term expires in all countries for all Licensed Products. Grifols may terminate the License immediately if (i) the Company or one of its affiliates files a challenge to a Grifols Patent or (ii) the Company fails to develop Licensed Products or execute its Development Plan (as defined in the License) by failing to allocate material funds, full-time equivalents and resources for twelve (12) consecutive months (net of any delay due to force majeure). Either party can terminate for the other party’s material breach following a cure period or upon certain insolvency events. The License also contains customary representations, warranties, mutual indemnities, limitations of liability, and confidentiality provisions. The Company also incurred approximately $0.5 million in legal fees in conjunction with the License of which $0.3 million and $0.2 million were incurred and expensed in the year ended December 31, 2019 and during the three months ended March 31, 2020, respectively. |
Fair Value Measurements
Fair Value Measurements | 3 Months Ended |
Mar. 31, 2020 | |
Fair Value Disclosures [Abstract] | |
Fair Value Measurements | 8. 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, commercial paper, and asset-backed securities 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 financial instruments. The Company’s foreign exchange derivative instruments are typically short-term in nature. The fair value of these instruments as of March 31, 2020 and December 31, 2019 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 March 31, 2020 Cash equivalents: U.S. Treasury money market funds $ 30,268 $ — $ — Short-term investments: U.S. government securities $ 15,745 $ — $ — Asset backed securities — 3,027 — Corporate securities — 25,339 — Commercial paper — 26,361 — Other liabilities: Foreign exchange derivatives not designated as hedging instruments $ — $ 88 $ — As of December 31, 2019 Cash equivalents: U.S. Treasury money market funds $ 13,530 $ — $ — Repurchase agreements — 6,000 — Short-term investments: U.S. government securities $ 15,638 $ — $ — Asset backed securities — 8,799 — Corporate securities — 30,585 — Commercial paper — 16,935 — Other assets: Foreign exchange derivatives not designated as hedging instruments $ — $ 7 $ — The following table sets forth a summary of the changes in the fair value of the Company’s Level 3 financial instruments (in thousands) for the year ended December 31, 2019 as there were no Level 3 financial instruments for the three months ended March 31, 2020: Contingent Consideration Balance at December 31, 2018 $ 12,214 Change in fair value 219 Settlement of contingent liability (12,433 ) Balance at December 31, 2019 $ — The Company did not transfer any assets measured at fair value on a recurring basis to or from Level 1, Level 2, and Level 3 during the three months ended March 31, 2020 and year ended December 31, 2019. |
Derivative Financial Instrument
Derivative Financial Instruments | 3 Months Ended |
Mar. 31, 2020 | |
Derivative Instruments And Hedging Activities Disclosure [Abstract] | |
Derivative Financial Instruments | 9. 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 and the exchange rate at the contract inception date were recognized in “Other income, net” in the condensed consolidated statements of operations and comprehensive loss. As of March 31, 2020, there was an asset of approximately $6 million consisting of unsettled forward exchange contracts to purchase foreign currency and a corresponding liability of approximately $6 million consisting of forward exchange contract obligations, resulting in a net derivative financial instrument of approximatley $0.1 million, recorded at their estimated fair value in “Accrued expenses and other current liabilities.” |
Shareholders' Equity
Shareholders' Equity | 3 Months Ended |
Mar. 31, 2020 | |
Equity [Abstract] | |
Shareholders' Equity | 10. Shareholders’ Equity Common Stock Sales Agreement On April 28, 2017, the Company entered into a Common Stock Sales Agreement with H.C. Wainwright & Co., LLC (“Wainwright”), as sales agent, which was amended by Amendment No. 1 to the Common Stock Sales Agreement (the “Amendment”) on June 29, 2018 (the “Sales Agreement”), 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 $60 million, in addition to the $2.3 million in shares sold prior to the Amendment. The Amendment was effective on July 13, 2018, the date the Company’s shelf registration agreement on Form S-3, as filed with the Securities and Exchange Commission on June 29, 2018, was declared effective (“New Registration Statement”) by the Securities and Exchange Commission. The Shares will be offered and sold pursuant to the New Registration Statement. 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% 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 three months ended March 31, 2020, the Company did not sell any shares of common stock under the Sales Agreement. Common Stock The Company’s amended and restated certificate of incorporation authorizes the Company to issue 201 million shares of common and preferred stock, consisting of 200 million shares of common stock with $0.001 par value and one million shares of preferred stock with $0.001 par value. The following is a summary of the Company’s common stock at March 31, 2020 and December 31, 2019. March 31, 2020 December 31, 2019 Common stock authorized 200,000,000 200,000,000 Common stock outstanding 50,844,504 50,790,441 The Company’s shares of common stock reserved for issuance as of March 31, 2020 and December 31, 2019 were as follows: March 31, 2020 December 31, 2019 Warrants acquired in merger 403,927 403,927 Warrants converted in connection with merger 72,869 72,869 April 2017 Warrants 24,725 24,725 June 2017 Warrants 41,736 41,736 December 2018 Warrants 11,332 11,332 2017 Pre-funded Warrants 775,000 775,000 Pre-funded PIPE Warrants 5,780,537 5,780,537 Milestone Warrants 32,577,209 32,577,209 Stock options outstanding 4,473,477 4,541,432 Issued and nonvested RSUs 302,875 315,625 Total shares reserved 44,463,687 44,544,392 Warrants The following table summarizes the outstanding warrants for the Company’s common stock as of March 31, 2020: Shares Underlying Outstanding Warrants Exercise Price Expiration Date 403,927 $ 29.40 February 2021 72,869 $ 8.98 June 2021 775,000 $ 0.01 October 2024 24,725 $ 2.87 April 2027 41,736 $ 2.87 June 2027 11,332 $ 2.87 December 2028 5,780,537 $ 0.001 None 32,577,209 $ 1.48 December 2021 or 30 days after clinical milestone 39,687,335 |
Commitments
Commitments | 3 Months Ended |
Mar. 31, 2020 | |
Commitments And Contingencies Disclosure [Abstract] | |
Commitments | 11. Commitments Operating Leases We are obligated under operating leases and subleases for office space. On November 29, 2017, we entered into a sublease agreement for office space for our corporate headquarters in Austin, Texas. The term of the sublease commenced on January 1, 2018 and will continue until July 31, 2021, with annual rental payments of approximately $0.2 million, paid over monthly installments, subject to increases of approximately 2% annually on the anniversary of the commencement date of the sublease term. However, monthly base rent for the first month of the sublease term was abated. We lease office space in Copenhagen, Denmark under a lease with an effective date of November 1, 2018 and that expires on September 30, 2022. The lease in Copenhagen can be terminated by the lessee and lessor no earlier than March 31, 2022 for vacating the premises by September 30, 2022 and contains an option to extend the lease term to remain in force until it is terminated in writing by either the lessee or lessor with a six month notice period from the first day of the month following September 30, 2022. For the quarter ended March 31, 2020, it is not reasonably certain the Company will exercise the extension options inherent in the lease. Our annual rent is approximately $0.1 million, paid over monthly installments, subject to annual increases equal to the Danish consumer price index, or approximately 2% annually. 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 a predecessor’s corporate headquarters, to a third party as the Company no longer had an ongoing need for this facility. 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. As of December 31, 2019, annual rent under the sub-sublease is approximately $0.5 million, payable in monthly installments. The following is a maturity analysis of the annual undiscounted cash flows reconciled to the carrying value of the operating lease liabilities as of March 31, 2020 (in thousands): Year ending December 31, 2020 276 2021 183 2022 67 Total future minimum lease payments $ 526 Less imputed interest (23 ) Total $ 503 For the three months ended March 31, 2020 Lease cost: Operating lease cost $ 385 Sublease income (136 ) Total lease cost $ 249 Other information: Operating cash flows from operating leases $ 200 Weighted-average remaining lease term (in months) - operating leases 18.9 Weighted-average discount rate - operating leases 8.5 % As of March 31, 2020, the carrying value of the right-of-use assets for the operating leases was $0.5 million, which is reflected in “Other non-current assets,” and the carrying value of the lease liabilities for operating leases was $0.5 million, of which $0.3 million related to the current portion of the lease liabilities is recorded in “Accrued expenses and other current liabilities,” and $0.2 million related to the non-current portion of the lease liabilities is recorded in “Other long-term liabilities.” Risk Management The Company maintains various forms of insurance that the Company's management believes are adequate to reduce the exposure to certain risks associated with operating the Company’s business to an acceptable level. Employment Agreements Certain executive officers are entitled to payments if they are terminated without cause or resign for good reason (each as defined in the employment agreements). Upon termination without cause, and not as a result of death or disability or resignation for good reason, each of such officers is entitled to receive a payment of base salary for twelve months and a pro-rated portion of their unpaid bonus following termination of employment, and such officer will be entitled to continue to receive coverage under medical and dental benefit plans for twelve months or until such officer is covered under a separate plan from another employer. Upon a termination other than for cause or resignation for good reason within twelve months following a change in control, each of such officers is entitled to receive a payment of base salary for eighteen months and one-hundred percent of their unpaid bonus following termination of employment and such officer will be entitled to continue to receive coverage under medical and dental benefit plans for twelve months or until such officer is covered under a separate plan from another employer and will also be entitled to certain acceleration of such officer’s outstanding nonvested options at the time of such termination. |
Stock-Based Compensation
Stock-Based Compensation | 3 Months Ended |
Mar. 31, 2020 | |
Disclosure Of Compensation Related Costs Sharebased Payments [Abstract] | |
Stock-Based Compensation | 12. Stock-Based Compensation A. Equity Incentive Plans 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 (i) the option grant program providing for both incentive and non-qualified stock options, as defined by the Internal Revenue Code, and (ii) 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 nonvested shares issued in conjunction with the stock issuance program at the fair market value per share as of the date of termination. The Company had previously 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, were 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. The Company no longer issues stock-based awards under the 2008 Plan. 2015 Omnibus Incentive Option Plan The Company operates the 2015 Omnibus Incentive Plan (the “2015 Plan”), the amendment and restatement of which was approved by stockholders in June 2018. The 2015 Plan provides for the grant of incentive and non-statutory stock options, as well as share appreciation rights, restricted shares, restricted stock units, performance units, shares and other stock-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 March 31, 2020, the number of shares of our common stock available for grant under the 2015 Plan was 298,853 shares. B. Stock Option 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 C. Stock-Based Award Activity The following table provides a summary of stock-based awards for the 2008 Plan and 2015 Plan for the three months ended March 31, 2020 and 2019: Three months ended March 31, 2020 Three months ended March 31, 2019 Stock Options RSUs Total Stock Options RSUs Total Outstanding as of December 31 4,541,432 315,625 4,857,057 3,077,264 156,250 3,233,514 Granted 12,000 — 12,000 90,000 — 90,000 Exercised (41,313 ) (12,750 ) (54,063 ) (23,593 ) (13,125 ) (36,718 ) Forfeited (38,642 ) — (38,642 ) (9,844 ) — (9,844 ) Outstanding as of March 31 4,473,477 302,875 4,776,352 3,133,827 143,125 3,276,952 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 three months ended March 31, 2020 and 2019 (in thousands): Three Months Ended March 31, 2020 March 31, 2019 Research and development $ 593 $ 452 General and administrative 601 548 Total stock-based compensation $ 1,194 $ 1,000 |
Net Loss Per Share
Net Loss Per Share | 3 Months Ended |
Mar. 31, 2020 | |
Earnings Per Share [Abstract] | |
Net Loss Per Share | 13. Net Loss per Share Basic and diluted net loss per share is computed by dividing net loss by the weighted-average number of common stock outstanding during the period. For periods in which the Company generated a net loss, the Company does not include the potential impact of dilutive securities in diluted net loss per share, as the impact of these items is anti-dilutive. The following weighted-average equity instruments were excluded from the calculation of diluted net loss per share because their effect would have been anti-dilutive for the periods presented: Three Months Ended March 31, 2020 March 31, 2019 Awards under equity incentive plan 4,473,477 3,133,827 Nonvested restricted shares and restricted stock units 302,875 143,125 Warrants to purchase common stock 33,131,798 901,502 Total 37,908,150 4,178,454 The following table calculates basic earnings per share of common stock and diluted earnings per share of common stock for the three months ended March 31, 2020 and 2019 (in thousands, except share and per share amounts): Three Months Ended March 31, 2020 March 31, 2019 Net loss $ (15,421 ) $ (12,112 ) Net loss attributable to common stockholders (15,421 ) (12,112 ) Undistributed earnings and net loss attributable to common stockholders, basic and diluted (15,421 ) (12,112 ) Weighted average common shares outstanding, basic and diluted 57,364,265 36,016,406 Basic and diluted EPS $ (0.27 ) $ (0.34 ) The weighted average common shares outstanding, basic and diluted, for the three months ended March 31, 2020, includes one million shares due under the License (see Note 7), which were not issued to licensor until after March 31, 2020, and pre-funded warrants outstanding during the period. |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Policies) | 3 Months Ended |
Mar. 31, 2020 | |
Accounting Policies [Abstract] | |
Basis of Presentation | Basis of Presentation The interim condensed 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”). These condensed consolidated financial statements should be read in conjunction with the audited financial statements and notes thereto for the year ended December 31, 2019. Certain prior period amounts have been reclassified for consistency with current period presentation. |
Unaudited Interim Financial Information | Unaudited Interim Financial Information The interim condensed consolidated financial statements included in this document are unaudited. The unaudited interim financial statements have been prepared on the same basis as the annual financial statements and reflect, in the opinion of management, all adjustments of a normal and recurring nature that are necessary for a fair statement of the Company’s financial position as of March 31, 2020, and its results of operations for the three months ended March 31, 2020 and 2019, and cash flows for the three months ended March 31, 2020 and 2019. The results of operations for interim periods shown in this report are not necessarily indicative of the results to be expected for the year ending December 31, 2020 or for any other future annual or interim period. The December 31, 2019 consolidated balance sheet was derived from audited financial statements but does not include all disclosures required by U.S. GAAP. These condensed consolidated financial statements should be read in conjunction with the audited financial statements and notes thereto for the year ended December 31, 2019. |
Liquidity | Liquidity As of March 31, 2020, the Company had an accumulated deficit of approximately $223.3 million. The Company also had negative cash flow from operations of approximately $13.1 million during the three months ended March 31, 2020. 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. Currently, the Company is primarily focused 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 is also continuously and critically reviewing our liquidity and anticipated capital requirements in light of the uncertainty resulting from the COVID-19 global pandemic. While the Company had cash and cash equivalents of $34.5 million and short-term investments of $70.5 million as of March 31, 2020, the Company intends to continue to raise additional capital as needed through the issuance of additional equity securities 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 condensed consolidated financial statements do not include any adjustments that might result from the outcome of this uncertainty. |
Principles of Consolidation | Principles of Consolidation The interim condensed 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 (loss).” 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 and general and administrative costs, certain financial instruments recorded at fair value, contingent consideration, 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. |
Short-term Investments | Short-term Investments The Company has classified its investments in debt 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 reflected as a part of “Accumulated other comprehensive income 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 or expensed 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. To date, 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 available information and, in some cases, assumptions with respect to the timing and amount of future revenue and expenses associated with an asset. |
License and Collaboration Agreements | License and Collaboration Agreements The Company enters into license and collaboration agreements with third parties whereby the Company purchases the rights to develop, market, sell and/or distribute the underlying pharmaceutical products or drug candidates. Pursuant to these agreements, the Company is generally required to make up-front payments, milestone payments contingent upon the achievement of certain pre-determined criteria, royalty payments based on specified sales levels of the underlying products and/or certain other payments. Up-front payments are either expensed immediately as research and development or capitalized. The determination to capitalize amounts related to licenses is based on management’s judgments with respect to stage of development, the nature of the rights acquired, alternative future uses, developmental and regulatory issues and challenges, the net realizable value of such amounts based on projected sales of the underlying products, the commercial status of the underlying products, and/or various other competitive factors. Milestone payments made prior to regulatory approval are generally expensed as incurred and milestone payments made subsequent to regulatory approval are generally capitalized as an intangible asset. Royalty payments are expensed as incurred. Other payments made pursuant to license and collaboration agreements, which are generally related to research and development activities, are expensed as incurred. |
Goodwill, Acquired In-Process Research and Development, and Deferred Tax Liability | Goodwill, Acquired In-Process Research and Development, and Deferred Tax Liability Although the Company does not have any goodwill as of March 31, 2020, it has adopted the following accounting policy. Goodwill represents the excess of purchase price over the fair value of net assets acquired by the Company. Goodwill is not amortized but assessed for impairment on an annual basis or more frequently if impairment indicators exist. Current guidance issued by the FASB, as previously adopted by the Company, provides an impairment model whereby the Company has the option to implement a one-step method for determining impairment of goodwill, simplifying the subsequent measurement of goodwill by eliminating Step 2 (quantitative calculation of measuring a goodwill impairment loss by comparing the implied fair value of a reporting unit’s goodwill with the carrying amount of that goodwill) from the goodwill impairment test. Under the amendments in this guidance, an entity should perform its annual goodwill impairment test by comparing the fair value of a reporting unit with its carrying amount. An entity should recognize an impairment charge for the amount by which the carrying amount exceeds the reporting unit’s fair value; however, the loss recognized should not exceed the total amount of goodwill allocated to that reporting unit. Additionally, an entity should consider income tax effects from any tax-deductible goodwill on the carrying amount of the reporting unit when measuring the goodwill impairment loss, if applicable. Acquired in-process research and development (“IPR&D”) is considered an indefinite-lived intangible asset and is assessed for impairment annually or more frequently if impairment indicators exist. For instance, based upon the ultimate scope and scale of the COVID - 19 global pandemic, there may be materially negative impacts to the assumptions made with respect to our IPR&D assets that could result in an impairment of such assets. For the three months ended March 31, 2020, the impact of COVID-19 did not trigger any impairment indicators. The Company adopted accounting guidance related to its annual acquired IPR&D impairment test, a two-step method, 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 IPR&D is more likely than not less than the carrying amount, a quantitative impairment test is required. If the associated research and development effort is abandoned, the related asset will be written-off, and the Company will record a noncash impairment loss on its consolidated statements of operations and comprehensive loss. For those products that reach commercialization, the IPR&D asset will be amortized over its estimated useful life. The Company performs its annual goodwill impairment test and IPR&D impairment test, as described above, as of June 30th and September 30th, respectively, or whenever an event or change in circumstances occurs that would require reassessment of the recoverability of those assets. For the three months ended March 31, 2020, the Company experienced a decrease of approximately $0.2 million in the carrying value of IPR&D, which was due to foreign currency translation. |
Tax Credit Receivable | Tax Credit Receivable The Company has recorded a Danish tax credit earned by its subsidiary, Savara ApS, as of March 31, 2020. 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. As of March 31, 2020, credits totaling $1.6 million had been generated but not yet received. Of this total Danish tax credit, $0.8 million is related to research and development activities incurred during the year ended December 31, 2019 and is recorded in “Prepaid expenses and other current assets” and expected to be received in the fourth quarter of 2020. The remaining portion of the Danish tax credit of $0.8 million, which was generated during the three months ended March 31, 2020, is recorded in “Other non-current assets” and is expected to be received in the fourth quarter of 2021. The Company also recognized tax credit income for the three months ended March 31, 2020 as provided by the Australian Taxation Office for qualified research and development expenditures incurred through our subsidiary, Savara Australia Pty. Limited. Under Australian tax law, Australia remits a research and development tax credit equal to 43.5% of qualified research and development expenditures, not to exceed established thresholds. As of March 31, 2020, credits totaling $0.5 million had been generated but not yet received. Of this total Australian tax credit, $0.4 million is related to research and development activities incurred during the year ended December 31, 2019 and is recorded in “Prepaid expenses and other current assets” and expected to be received during the year ending December 31, 2020. The remaining portion of the Australian tax credit of $0.1 million, which was generated during the three months ended March 31, 2020, is recorded in “Other non-current assets” and is expected to be received during the year ended December 31, 2021. |
Leases | Leases In February 2016, the FASB issued Accounting Standards Update (“ASU”) 2016-02, “Leases (Topic 842)” (“ASU 2016-02”) as codified in Accounting Standards Codification (“ASC”) 842 (“ASC 842”). ASU 2016-02, ASC 842, and additional issued guidance are intended to improve financial reporting of leasing transactions by requiring organizations that lease assets to recognize assets and liabilities for the rights and obligations created by leases that extend more than twelve months. This accounting update also requires additional disclosures surrounding the amount, timing, and uncertainty of cash flows arising from leases. ASU 2016-02 is effective for financial statements issued for annual and interim periods beginning after December 15, 2018 for public business entities. The Company adopted ASU 2016-02 as of January 1, 2019 using the effective date transition method of implementation offered under ASU 2018-11, “Leases (Topic 842) – Targeted Improvements” issued in July 2018 (“ASU 2018-11”), under which entities may change their date of initial application of ASU 2016-02 to the beginning of the period of adoption, or January 1, 2019, in the case of Savara. Accordingly, the Company is required to apply the prior lease guidance pursuant to ASC Topic 840 in the comparative periods, provide the disclosures required by ASC Topic 840 for all periods that continue to be presented in accordance with ASC Topic 840, recognize the effects of applying ASC 842 as a cumulative-effect adjustment to retained earnings as of January 1, 2019, if any, and provide certain disclosures under ASC 842 (see Note 11). The Company has also elected the package of practical expedients, applied by class of underlying asset, permitted in ASU 2018-11. Accordingly, the Company accounted for its existing operating leases as operating leases under the new guidance, without reassessing (a) whether the contracts contain a lease under ASC 842, (b) whether classification of the operating leases would be different in accordance with ASC 842, and (c) whether the unamortized initial direct costs before transition adjustments (as of the period of adoption) would have met the definition of initial direct costs in ASC 842 at lease commencement, and the Company did not separate lease and non-lease components. As a result of the adoption of the new lease accounting guidance using the effective date transition method, on January 1, 2019, the Company recognized (a) a lease liability of approximately $1.4 million, which represents the present value of the remaining lease payments, as of the date of adoption, of approximately $1.5 million, discounted using the Company’s incremental borrowing rate of 8.5%, and (b) a right-of-use asset of approximately $1.4 million. The adoption of the new standard did not result in any adjustment to the Company’s retained earnings as of January 1, 2019. The adoption of this standard did not have a material impact on the Company’s condensed consolidated balance sheets, cash used/provided from operating, investing, or financing activities in the condensed consolidated statements of cash flows, or on the Company’s operating results. The most significant impact was the recognition of right-of-use assets for operating leases, which are reflected in “Other non-current assets,” and lease liabilities for operating leases, which are reflected in “Accrued expenses and other current liabilities,” for the current portion of the lease liabilities, and in “Other long-term liabilities” for the non-current portion of the lease liabilities, respectively (See Note 11). |
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, short-term investments, and foreign exchange derivatives not designated as hedging instruments. 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. |
Revenue Recognition | Revenue Recognition The Company will record revenue based on a five-step model in accordance with ASC 606, “Revenue from Contracts with Customers.” To date, the Company has not generated any product revenue from its drug candidates. The Company’s ability to generate product revenues, which the Company does not expect will occur in the near term, if ever, will depend heavily on the successful development, regulatory approval, and eventual commercialization of the Company’s product candidates. |
Milestone Revenue | Milestone Revenue The Company is subject to a license agreement related to its Molgradex product candidate, which includes certain milestone payments to be remunerated by the licensee to Savara. In exchange, the Company granted the licensee an exclusive right to import, market, sell, distribute and promote Molgradex in Japan for the treatment of aPAP. Pursuant to the license agreement, the Company identifies the performance obligations, determines the transaction price, allocates the contract transaction price to the performance obligations, and recognizes the revenue when (or as) the performance obligation is satisfied. The Company identifies the performance obligations included within the license agreement and evaluates which performance obligations are distinct. The milestone payments are a form of variable consideration as the payments are contingent upon achievement of a substantive event. The milestone payments are estimated and included in the transaction price when the Company determines, under the variable consideration constraint, that it is probable that there will not be a significant reversal of cumulative revenue recognized in future periods. The transaction price is then allocated to each performance obligation on a relative stand-alone selling price basis, for which the Company recognizes revenue as or when the performance obligations under the contract are satisfied. At the end of each subsequent reporting period, the Company re-evaluates the probability of achievement of such milestones and any related constraint, and if necessary, adjusts the estimate of the overall transaction price. In October 2018, the Company achieved a milestone payment pursuant to this license agreement resulting in the receipt of $0.3 million from the licensee. As of March 31, 2020, the Company has determined that it has not met all of the performance obligations under this license agreement and, accordingly, has recorded the milestone payment as deferred revenue in “Accrued expenses and other current liabilities” in the Company’s condensed consolidated balance sheet until such time the performance obligations are met. On February 21, 2020, the Company received notification from the licensee of its intent to terminate this license agreement. Accordingly, this license agreement shall terminate on August 21, 2020 upon which the Company shall recognize revenue related to this $0.3 million milestone payment. |
Net Loss per Share | Net Loss per Share Basic net loss attributable to common stockholders per share is calculated by dividing the net loss attributable to common stockholders by the weighted average number of shares of common stock and pre-funded warrants 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. |
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 12). Forfeitures are recognized when they occur, which may result in the reversal of compensation costs in subsequent periods as the forfeitures arise. |
Manufacturing, Development, and Other Commitments and Contingencies | Manufacturing, Development, and Other Commitments and Contingencies The Company is subject to various royalties and manufacturing and development payments related to its product candidates, Molgradex and Apulmiq. Under a manufacture and supply agreement with the active pharmaceutical ingredients (“API”) manufacturer for Molgradex, Savara must make certain payments to the API manufacturer upon achievement of the milestones outlined in the table set forth below. Additionally, upon first receipt of marketing approval by Savara from a regulatory authority in a country for a product containing the API for therapeutic use in humans and ending the earlier of (i) ten (10) years thereafter or (ii) the date a biosimilar of such product is first sold in such country, Savara shall pay the API manufacturer a royalty equal to low-single digits of the net sales in that country. Under a license and collaboration agreement for the rights to develop and commercialize Apulmiq, the Company is subject to certain contingent development payments and contingent sales payments due to the licensor upon the achievement of certain milestones up to amounts as set forth in the following table (see Note 7). The Company will also owe the licensor low double-digit tiered royalties based on annual global net sales of licensed products (on a product-by-product basis), which are subject to reduction if another inhaled ciprofloxacin product is introduced into the market. Under an agreement with a medical education and research foundation entered into on October 8, 2018, the Company is subject to a milestone payment for the use of proprietary information and material in intellectual property filings related to the application of Molgradex in the treatment of NTM. The Company will owe royalties to the foundation based on net sales of Molgradex for the treatment of NTM equal to one half of one percent (0.5%) after publication of the intellectual property filings and one quarter of one percent (0.25%) prior to the publication or in the event publication does not occur, with respect to the specified intellectual property filings. The Company is also subject to certain contingent milestone payments, disclosed in the following table, payable to the manufacturer of the nebulizer used to administer Molgradex. The change in the amount of the milestone payments from December 31, 2019 to March 31, 2020 was related to Manufacturing, Development, and Other Contingent Milestone Payments (in thousands): March 31, 2020 Molgradex API manufacturer: Achievement of certain milestones related to validation of API and regulatory approval of Molgradex $ 2,300 Molgradex nebulizer manufacturer: Achievement of various development activities and regulatory approval of nebulizer utilized to administer Molgradex 7,331 Medical education and research foundation (Molgradex): First commercial sale in the U.S. of Molgradex in treatment of NTM 500 Apulmiq Licensor: Achievement of various development activities and regulatory approval of Apulmiq for the treatment of NCFB 50,000 Achievement of various sales activities of Apulmiq for treatment of NCFB 100,000 Total manufacturing and other commitments $ 160,131 The milestone commitments disclosed above reflect the activities that have (i) not been met or incurred; (ii) not been remunerated; and (iii) not accrued, as the activities are not deemed probable or reasonably estimable, as of March 31, 2020. |
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 February 2020, the FASB issued ASU 2020-02, “Financial Instruments—Credit Losses (Topic 326) and Leases (Topic 842)—Amendments to SEC Paragraphs Pursuant to SEC Staff Accounting Bulletin No. 119 and Update to SEC Section on Effective Date Related to Accounting Standards Update 2016-02, Leases (Topic 842) (SEC Update).” The company has reviewed ASU 2020-02 and concluded that it does not have a material impact on our condensed consolidated financial statements. In March 2020, the FASB issued ASU 2020-03, “Codification Improvements to Financial Instruments,” which addressed various issues including the following: (i) clarification that all entities are required to provide the (“ASU 2020-03”) fair value option disclosures in paragraphs 825-10-50-24 through 50-32 of the FASB’s ASC, (ii) clarification that the contractual term of a net investment in a lease determined in accordance with ASC 842, “Leases,” should be the contractual term used to measure expected credit losses under ASC 326, “Financial Instruments – Credit Losses,” and (iii) amendment of ASC 860-20, “Transfers and Servicing – Sales of Financial Assets,” clarifying that when an entity regains control of financial assets sold, an allowance for credit losses should be recorded in accordance with ASC 326. The Company has reviewed ASU 2020-3 and concluded that it does not have a material impact on our condensed consolidated financial statements. In March 2020, the FASB issued ASU 2020-04, “Reference Rate Reform (Topic 848)” which provides optional guidance for a limited period of time to ease the potential burden in accounting for the effects of the transition away from LIBOR and other reference rates.” The company has reviewed ASU 2020-04 and concluded that it has no impact on our condensed consolidated financial statements. |
Summary of Significant Accoun_3
Summary of Significant Accounting Policies (Tables) | 3 Months Ended |
Mar. 31, 2020 | |
Accounting Policies [Abstract] | |
Schedule of Manufacturing, Development, and Other Contingent Milestone Payments | Manufacturing, Development, and Other Contingent Milestone Payments (in thousands): March 31, 2020 Molgradex API manufacturer: Achievement of certain milestones related to validation of API and regulatory approval of Molgradex $ 2,300 Molgradex nebulizer manufacturer: Achievement of various development activities and regulatory approval of nebulizer utilized to administer Molgradex 7,331 Medical education and research foundation (Molgradex): First commercial sale in the U.S. of Molgradex in treatment of NTM 500 Apulmiq Licensor: Achievement of various development activities and regulatory approval of Apulmiq for the treatment of NCFB 50,000 Achievement of various sales activities of Apulmiq for treatment of NCFB 100,000 Total manufacturing and other commitments $ 160,131 |
Prepaid Expenses and Other Cu_2
Prepaid Expenses and Other Current Assets (Tables) | 3 Months Ended |
Mar. 31, 2020 | |
Prepaid Expense And Other Assets Current [Abstract] | |
Schedule of Prepaid Expenses and Other Current Assets | Prepaid expenses consisted of (in thousands): March 31, 2020 December 31, 2019 R&D tax credit receivable $ 1,233 $ 1,253 Prepaid contracted research and development costs 422 184 VAT receivable 356 364 Prepaid insurance 86 247 Foreign currency exchange derivative — 7 Deposits and other 361 251 Total prepaid expenses and other current assets $ 2,458 $ 2,306 |
Accrued Expenses and Other Cu_2
Accrued Expenses and Other Current Liabilities (Tables) | 3 Months Ended |
Mar. 31, 2020 | |
Payables And Accruals [Abstract] | |
Summary of Accrued Expenses and Other Current Liabilities | Accrued expenses and other current liabilities consisted of (in thousands): March 31, 2020 December 31, 2019 Accrued contracted research and development costs $ 2,100 $ 2,018 Accrued general and administrative costs 820 1,710 Accrued closing costs for previous issuance of securities in private placement 120 — Accrued compensation 705 1,303 Foreign currency exchange derivative 88 — Deferred revenue 238 — Common stock due for in-licensing of development and commercialization rights 2,120 — Lease liability 311 440 Total accrued expenses and other current liabilities $ 6,502 $ 5,471 |
Short-term Investments (Tables)
Short-term Investments (Tables) | 3 Months Ended |
Mar. 31, 2020 | |
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 (in thousands): As of March 31, 2020 Amortized Cost Gross Unrealized Gains Gross Unrealized Losses Fair Value Short-term investments U.S. government securities $ 15,624 $ 121 $ — $ 15,745 Asset backed securities 3,027 — — 3,027 Corporate securities 25,395 6 (62 ) 25,339 Commercial paper 26,361 — — 26,361 Total short-term investments $ 70,407 $ 127 $ (62 ) $ 70,472 As of December 31, 2019 Amortized Cost Gross Unrealized Gains Gross Unrealized Losses Fair Value Short-term investments U.S. government securities $ 15,629 $ 11 $ (2 ) $ 15,638 Asset backed securities 8,789 10 — 8,799 Corporate securities 30,556 30 (1 ) 30,585 Commercial paper 16,935 — — 16,935 Total short-term investments $ 71,909 $ 51 $ (3 ) $ 71,957 |
Debt Facility (Tables)
Debt Facility (Tables) | 3 Months Ended |
Mar. 31, 2020 | |
Debt Disclosure [Abstract] | |
Summary of Components of Debt Facility Carrying Value | The following table summarizes the components of the debt facility carrying value, which approximates the fair value (in thousands): As of March 31, 2020 Short-term Long-term Principal payments to lender and end of term charge $ — $ 25,064 Debt Issuance costs $ (189 ) Debt discount related to warrants — (144 ) Carrying Value $ — $ 24,731 |
Fair Value Measurements (Tables
Fair Value Measurements (Tables) | 3 Months Ended |
Mar. 31, 2020 | |
Fair Value Disclosures [Abstract] | |
Summary of Fair Value of Financial Instruments | The fair value of these instruments as of March 31, 2020 and December 31, 2019 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 March 31, 2020 Cash equivalents: U.S. Treasury money market funds $ 30,268 $ — $ — Short-term investments: U.S. government securities $ 15,745 $ — $ — Asset backed securities — 3,027 — Corporate securities — 25,339 — Commercial paper — 26,361 — Other liabilities: Foreign exchange derivatives not designated as hedging instruments $ — $ 88 $ — As of December 31, 2019 Cash equivalents: U.S. Treasury money market funds $ 13,530 $ — $ — Repurchase agreements — 6,000 — Short-term investments: U.S. government securities $ 15,638 $ — $ — Asset backed securities — 8,799 — Corporate securities — 30,585 — Commercial paper — 16,935 — Other assets: Foreign exchange derivatives not designated as hedging instruments $ — $ 7 $ — |
Summary of Changes in Fair Value of Company's Level 3 Financial Instruments | The following table sets forth a summary of the changes in the fair value of the Company’s Level 3 financial instruments (in thousands) for the year ended December 31, 2019 as there were no Level 3 financial instruments for the three months ended March 31, 2020: Contingent Consideration Balance at December 31, 2018 $ 12,214 Change in fair value 219 Settlement of contingent liability (12,433 ) Balance at December 31, 2019 $ — |
Shareholders' Equity (Tables)
Shareholders' Equity (Tables) | 3 Months Ended |
Mar. 31, 2020 | |
Equity [Abstract] | |
Summary of Company's Common Stock | The following is a summary of the Company’s common stock at March 31, 2020 and December 31, 2019. March 31, 2020 December 31, 2019 Common stock authorized 200,000,000 200,000,000 Common stock outstanding 50,844,504 50,790,441 |
Company's Shares of Common Stock Reserved for Issuance | The Company’s shares of common stock reserved for issuance as of March 31, 2020 and December 31, 2019 were as follows: March 31, 2020 December 31, 2019 Warrants acquired in merger 403,927 403,927 Warrants converted in connection with merger 72,869 72,869 April 2017 Warrants 24,725 24,725 June 2017 Warrants 41,736 41,736 December 2018 Warrants 11,332 11,332 2017 Pre-funded Warrants 775,000 775,000 Pre-funded PIPE Warrants 5,780,537 5,780,537 Milestone Warrants 32,577,209 32,577,209 Stock options outstanding 4,473,477 4,541,432 Issued and nonvested RSUs 302,875 315,625 Total shares reserved 44,463,687 44,544,392 |
Summary of Outstanding Warrants for Company's Common Stock | The following table summarizes the outstanding warrants for the Company’s common stock as of March 31, 2020: Shares Underlying Outstanding Warrants Exercise Price Expiration Date 403,927 $ 29.40 February 2021 72,869 $ 8.98 June 2021 775,000 $ 0.01 October 2024 24,725 $ 2.87 April 2027 41,736 $ 2.87 June 2027 11,332 $ 2.87 December 2028 5,780,537 $ 0.001 None 32,577,209 $ 1.48 December 2021 or 30 days after clinical milestone 39,687,335 |
Commitments (Tables)
Commitments (Tables) | 3 Months Ended |
Mar. 31, 2020 | |
Commitments And Contingencies Disclosure [Abstract] | |
Schedule of Maturity Analysis of Annual Undiscounted Cash Flows Reconciled to Carrying Value of Operating Lease Liabilities | The following is a maturity analysis of the annual undiscounted cash flows reconciled to the carrying value of the operating lease liabilities as of March 31, 2020 (in thousands): Year ending December 31, 2020 276 2021 183 2022 67 Total future minimum lease payments $ 526 Less imputed interest (23 ) Total $ 503 |
Schedule of Lease Cost and Other Information | For the three months ended March 31, 2020 Lease cost: Operating lease cost $ 385 Sublease income (136 ) Total lease cost $ 249 Other information: Operating cash flows from operating leases $ 200 Weighted-average remaining lease term (in months) - operating leases 18.9 Weighted-average discount rate - operating leases 8.5 % |
Stock-Based Compensation (Table
Stock-Based Compensation (Tables) | 3 Months Ended |
Mar. 31, 2020 | |
Disclosure Of Compensation Related Costs Sharebased Payments [Abstract] | |
Summary of Stock-based Awards for 2008 Plan and 2015 Plan | The following table provides a summary of stock-based awards for the 2008 Plan and 2015 Plan for the three months ended March 31, 2020 and 2019: Three months ended March 31, 2020 Three months ended March 31, 2019 Stock Options RSUs Total Stock Options RSUs Total Outstanding as of December 31 4,541,432 315,625 4,857,057 3,077,264 156,250 3,233,514 Granted 12,000 — 12,000 90,000 — 90,000 Exercised (41,313 ) (12,750 ) (54,063 ) (23,593 ) (13,125 ) (36,718 ) Forfeited (38,642 ) — (38,642 ) (9,844 ) — (9,844 ) Outstanding as of March 31 4,473,477 302,875 4,776,352 3,133,827 143,125 3,276,952 |
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 three months ended March 31, 2020 and 2019 (in thousands): Three Months Ended March 31, 2020 March 31, 2019 Research and development $ 593 $ 452 General and administrative 601 548 Total stock-based compensation $ 1,194 $ 1,000 |
Net Loss Per Share (Tables)
Net Loss Per Share (Tables) | 3 Months Ended |
Mar. 31, 2020 | |
Earnings Per Share [Abstract] | |
Schedule of Anti-dilutive Weighted-Average Equity Instruments Excluded from Calculation of Diluted Net Loss Per Share | The following weighted-average equity instruments were excluded from the calculation of diluted net loss per share because their effect would have been anti-dilutive for the periods presented: Three Months Ended March 31, 2020 March 31, 2019 Awards under equity incentive plan 4,473,477 3,133,827 Nonvested restricted shares and restricted stock units 302,875 143,125 Warrants to purchase common stock 33,131,798 901,502 Total 37,908,150 4,178,454 |
Reconciles Basic Earnings Per Share and Diluted Earnings Per Share of Common Stock | The following table calculates basic earnings per share of common stock and diluted earnings per share of common stock for the three months ended March 31, 2020 and 2019 (in thousands, except share and per share amounts): Three Months Ended March 31, 2020 March 31, 2019 Net loss $ (15,421 ) $ (12,112 ) Net loss attributable to common stockholders (15,421 ) (12,112 ) Undistributed earnings and net loss attributable to common stockholders, basic and diluted (15,421 ) (12,112 ) Weighted average common shares outstanding, basic and diluted 57,364,265 36,016,406 Basic and diluted EPS $ (0.27 ) $ (0.34 ) |
Description of Business and B_2
Description of Business and Basis of Presentation - Additional Information (Detail) | 3 Months Ended |
Mar. 31, 2020USD ($)CompoundSegment | |
Organization Consolidation And Presentation Of Financial Statements [Abstract] | |
Number of investigational compounds | Compound | 3 |
Number of operating segments | Segment | 1 |
Product revenue from inception to date | $ | $ 0 |
Type of Revenue [Extensible List] | us-gaap:ProductMember |
Summary of Significant Accoun_4
Summary of Significant Accounting Policies - Additional Information (Detail) € in Millions | Feb. 21, 2020USD ($) | Oct. 31, 2018USD ($) | Mar. 31, 2020USD ($)Segment | Mar. 31, 2019USD ($) | Mar. 31, 2020EUR (€) | Dec. 31, 2019USD ($) | Jan. 01, 2019USD ($) |
Summary Of Significant Accounting Policies [Line Items] | |||||||
Accumulated deficit | $ (223,313,000) | $ (207,892,000) | |||||
Cash flow from operations | (13,079,000) | $ (10,859,000) | |||||
Cash and cash equivalents | 34,515,000 | 49,804,000 | |||||
Short-term investments | $ 70,472,000 | 71,957,000 | |||||
Cash and cash equivalents with original maturities | three months or less | ||||||
Goodwill | $ 0 | ||||||
Carrying value of IPR&D | 200,000 | ||||||
Operating lease, liability | 503,000 | ||||||
Present value of remaining lease payments | 526,000 | ||||||
Operating lease, right-of -use asset | $ 500,000 | ||||||
Discounted using incremental borrowing rate | 8.50% | 8.50% | |||||
Number of operating segments | Segment | 1 | ||||||
Date of agreement | Oct. 8, 2018 | ||||||
Contingent milestones commitments met or incurred | $ 0 | ||||||
Contingent milestones commitments met or remunerated | 0 | ||||||
Contingent milestones commitments accrued | 0 | ||||||
aPAP [Member] | |||||||
Summary Of Significant Accounting Policies [Line Items] | |||||||
Milestone payment accrued | $ 200,000 | ||||||
aPAP [Member] | Japan [Member] | |||||||
Summary Of Significant Accounting Policies [Line Items] | |||||||
Receipt of milestone payment | $ 300,000 | ||||||
Milestone payment receivable revenue recognized | $ 300,000 | ||||||
License agreement termination date | Aug. 21, 2020 | ||||||
Active Pharmaceutical Ingredients [Member] | |||||||
Summary Of Significant Accounting Policies [Line Items] | |||||||
Agreement description | Under a manufacture and supply agreement with the active pharmaceutical ingredients (“API”) manufacturer for Molgradex, Savara must make certain payments to the API manufacturer upon achievement of the milestones outlined in the table set forth below. Additionally, upon first receipt of marketing approval by Savara from a regulatory authority in a country for a product containing the API for therapeutic use in humans and ending the earlier of (i) ten (10) years thereafter or (ii) the date a biosimilar of such product is first sold in such country, Savara shall pay the API manufacturer a royalty equal to low-single digits of the net sales in that country. | ||||||
NTM [Member] | |||||||
Summary Of Significant Accounting Policies [Line Items] | |||||||
Royalty percent on net sale after publication of the intellectual property | 0.50% | ||||||
Royalty percent on net sale prior publication of the intellectual property | 0.25% | ||||||
Nebulizer [Member] | |||||||
Summary Of Significant Accounting Policies [Line Items] | |||||||
Milestone payment accrued | € | € 4.3 | ||||||
Nebulizer [Member] | Minimum [Member] | |||||||
Summary Of Significant Accounting Policies [Line Items] | |||||||
Royalty percent on net sale | 3.50% | ||||||
Nebulizer [Member] | Maximum [Member] | |||||||
Summary Of Significant Accounting Policies [Line Items] | |||||||
Royalty percent on net sale | 5.00% | ||||||
ASC 842 | |||||||
Summary Of Significant Accounting Policies [Line Items] | |||||||
Operating lease, liability | $ 1,400,000 | ||||||
Present value of remaining lease payments | 1,500,000 | ||||||
Operating lease, right-of -use asset | $ 1,400,000 | ||||||
Discounted using incremental borrowing rate | 8.50% | ||||||
Savara ApS [Member] | |||||||
Summary Of Significant Accounting Policies [Line Items] | |||||||
Research and development tax credits | 22.00% | ||||||
Research and development tax credits receivable | $ 1,600,000 | ||||||
Savara ApS [Member] | Prepaid Expenses and Other Current Assets [Member] | |||||||
Summary Of Significant Accounting Policies [Line Items] | |||||||
Research and development tax credits receivable | $ 800,000 | ||||||
Savara ApS [Member] | Other Non-Current Assets [Member] | |||||||
Summary Of Significant Accounting Policies [Line Items] | |||||||
Research and development tax credits receivable | $ 800,000 | ||||||
Savara Australia Pty Limited [Member] | |||||||
Summary Of Significant Accounting Policies [Line Items] | |||||||
Research and development tax credits | 43.50% | ||||||
Research and development tax credits receivable | $ 500,000 | ||||||
Savara Australia Pty Limited [Member] | Prepaid Expenses and Other Current Assets [Member] | |||||||
Summary Of Significant Accounting Policies [Line Items] | |||||||
Research and development tax credits receivable | 400,000 | ||||||
Savara Australia Pty Limited [Member] | Other Non-Current Assets [Member] | |||||||
Summary Of Significant Accounting Policies [Line Items] | |||||||
Research and development tax credits receivable | $ 100,000 |
Summary of Significant Accoun_5
Summary of Significant Accounting Policies - Schedule of Manufacturing, Development, and Other Contingent Milestone Payments (Detail) $ in Thousands | 3 Months Ended |
Mar. 31, 2020USD ($) | |
Summary Of Significant Accounting Policies [Line Items] | |
Total manufacturing and other commitments | $ 160,131 |
Active Pharmaceutical Ingredients [Member] | |
Summary Of Significant Accounting Policies [Line Items] | |
Achievement of certain milestones related to validation of API and regulatory approval of Molgradex | 2,300 |
Molgradex Nebulizer Manufacturer [Member] | |
Summary Of Significant Accounting Policies [Line Items] | |
Achievement of various development activities and regulatory approval | 7,331 |
NTM [Member] | |
Summary Of Significant Accounting Policies [Line Items] | |
First commercial sale in the U.S. of Molgradex in treatment of NTM | 500 |
Apulmiq Licensor [Member] | |
Summary Of Significant Accounting Policies [Line Items] | |
Achievement of various development activities and regulatory approval | 50,000 |
Achievement of various sales activities of Apulmiq for treatment of NCFB | $ 100,000 |
Prepaid Expenses and Other Cu_3
Prepaid Expenses and Other Current Assets - Summary of Prepaid Expenses and Other Current Assets (Detail) - USD ($) $ in Thousands | Mar. 31, 2020 | Dec. 31, 2019 |
Prepaid Expense And Other Assets Current [Abstract] | ||
R&D tax credit receivable | $ 1,233 | $ 1,253 |
Prepaid contracted research and development costs | 422 | 184 |
VAT receivable | 356 | 364 |
Prepaid insurance | 86 | 247 |
Foreign currency exchange derivative | 7 | |
Deposits and other | 361 | 251 |
Total prepaid expenses and other current assets | $ 2,458 | $ 2,306 |
Accrued Expenses and Other Cu_3
Accrued Expenses and Other Current Liabilities - Summary of Accrued Expenses and Other Current Liabilities (Detail) - USD ($) $ in Thousands | Mar. 31, 2020 | Dec. 31, 2019 |
Payables And Accruals [Abstract] | ||
Accrued contracted research and development costs | $ 2,100 | $ 2,018 |
Accrued general and administrative costs | 820 | 1,710 |
Accrued closing costs for previous issuance of securities in private placement | 120 | |
Accrued compensation | 705 | 1,303 |
Foreign currency exchange derivative | 88 | |
Deferred revenue | 238 | |
Common stock due for in-licensing of development and commercialization rights | 2,120 | |
Lease liability | 311 | 440 |
Total accrued expenses and other current liabilities | $ 6,502 | $ 5,471 |
Short-term Investments - Summar
Short-term Investments - Summary of Major Security and Type of Investments (Detail) - USD ($) $ in Thousands | Mar. 31, 2020 | Dec. 31, 2019 |
Schedule Of Available For Sale Securities [Line Items] | ||
Amortized Cost | $ 70,407 | $ 71,909 |
Gross Unrealized Gains | 127 | 51 |
Gross Unrealized Losses | (62) | (3) |
Fair Value | 70,472 | 71,957 |
U.S. Government Securities [Member] | ||
Schedule Of Available For Sale Securities [Line Items] | ||
Amortized Cost | 15,624 | 15,629 |
Gross Unrealized Gains | 121 | 11 |
Gross Unrealized Losses | (2) | |
Fair Value | 15,745 | 15,638 |
Asset Backed Securities [Member] | ||
Schedule Of Available For Sale Securities [Line Items] | ||
Amortized Cost | 3,027 | 8,789 |
Gross Unrealized Gains | 10 | |
Fair Value | 3,027 | 8,799 |
Corporate Securities [Member] | ||
Schedule Of Available For Sale Securities [Line Items] | ||
Amortized Cost | 25,395 | 30,556 |
Gross Unrealized Gains | 6 | 30 |
Gross Unrealized Losses | (62) | (1) |
Fair Value | 25,339 | 30,585 |
Commercial Paper [Member] | ||
Schedule Of Available For Sale Securities [Line Items] | ||
Amortized Cost | 26,361 | 16,935 |
Fair Value | $ 26,361 | $ 16,935 |
Short-term Investments - Additi
Short-term Investments - Additional Information (Detail) - USD ($) | 3 Months Ended | |
Mar. 31, 2020 | Mar. 31, 2019 | |
Investments Debt And Equity Securities [Abstract] | ||
Realized gains or losses on investments | $ 0 | $ 0 |
Debt Facility - Additional Info
Debt Facility - Additional Information (Detail) - USD ($) | Jan. 31, 2020 | Apr. 28, 2017 | Mar. 31, 2020 |
Line Of Credit Facility [Line Items] | |||
Warrants issued to purchase shares of common stock | 39,687,335 | ||
April 2017 Warrants [Member] | Common Stock [Member] | |||
Line Of Credit Facility [Line Items] | |||
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 | ||
June 2017 Warrants [Member] | Common Stock [Member] | |||
Line Of Credit Facility [Line Items] | |||
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 | ||
December 2018 Warrants [Member] | Common Stock [Member] | |||
Line Of Credit Facility [Line Items] | |||
Warrants issued to purchase shares of common stock | 11,332 | ||
Exercise price of warrants per share | $ 8.824 | ||
Warrants expiration term | 10 years | ||
Warrants expiration date | Dec. 4, 2028 | ||
April 2017 Warrants, June 2017 Warrants, and December 2018 Warrants [Member] | |||
Line Of Credit Facility [Line Items] | |||
Warrants issued to purchase shares of common stock | 77,793 | ||
Exercise price of warrants per share | $ 2.87 | ||
Loan and Security Agreement [Member] | Silicon Valley Bank [Member] | |||
Line Of Credit Facility [Line Items] | |||
Loan agreement amendment date | Oct. 31, 2017 | ||
Loan agreement amendment date one | Dec. 4, 2018 | ||
Loan and Security Agreement [Member] | Silicon Valley Bank [Member] | Term Loan [Member] | |||
Line Of Credit Facility [Line Items] | |||
Loan and security agreement, maximum amount | $ 25,000,000 | ||
Debt instrument payment description | the interest-only period of the loan repayment through June 30, 2022, with payments thereafter in equal monthly installments of principal plus interest over 18 months. However, if by March 31, 2021, the Company does not have an ongoing Phase 3 or Phase 4 clinical trial evaluating its Molgradex product for the treatment of aPAP in which the first patient has been dosed, the interest-only period will end and principal plus interest will be due in equal monthly installments over 24 months beginning on April 1, 2021. | ||
Frequency of principal plus interest repayment period | equal monthly installments | ||
Debt instrument principal and interest payment period | 18 months | ||
Payments of debt issuance costs | $ 500,000 | ||
Interest rate, basis spread | 3.00% | ||
Prepayment fee percentage | 7.75% | ||
Gross cash proceeds from sale of equity securities | $ 25,000,000 | ||
Loan and Security Agreement [Member] | Silicon Valley Bank [Member] | Term Loan [Member] | Prepayment Fee 13-24 Months [Member] | |||
Line Of Credit Facility [Line Items] | |||
Prepayment fee percentage | 2.00% | ||
Loan and Security Agreement [Member] | Silicon Valley Bank [Member] | Term Loan [Member] | Prepayment Fee Thereafter [Member] | |||
Line Of Credit Facility [Line Items] | |||
Prepayment fee percentage | 1.00% | ||
Loan and Security Agreement [Member] | Silicon Valley Bank [Member] | Term Loan [Member] | End of Term Charge [Member] | |||
Line Of Credit Facility [Line Items] | |||
Prepayment fee percentage | 6.00% |
Debt Facility - Summary of Comp
Debt Facility - Summary of Components of Debt Facility Carrying Value (Detail) - USD ($) $ in Thousands | Mar. 31, 2020 | Dec. 31, 2019 |
Debt Disclosure [Abstract] | ||
Carrying value, Short-term | $ 2,000 | |
Principal payments to lender and end of term charge, Long-term | $ 25,064 | |
Debt issuance costs, Long-term | (189) | |
Debt discount related to warrants, Long-term | (144) | |
Carrying value, Long-term | $ 24,731 | $ 23,112 |
Apulmiq License Agreement - Add
Apulmiq License Agreement - Additional Information (Details) - Apulmiq License Agreement [Member] - Grifols Patents [Member] - USD ($) shares in Millions | 3 Months Ended | 12 Months Ended |
Mar. 31, 2020 | Dec. 31, 2019 | |
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||
License agreement description | (1) a Licensed Product for the treatment of either NCFB or pulmonary infections associated with NCFB (the “Initial Indication”) and (2) any Licensed Product for another indication, of which none are currently approved, (an “Additional Indication”), including the conduct of a confirmatory Phase 3 clinical trial in the Initial Indication. | |
Upfront cash payment | $ 3,300,000 | |
Upfront payment common stock shares issued | 1 | |
Upfront payment value of common stock issued | $ 2,100,000 | |
Developmental milestone payments | 50,000,000 | |
Sales milestone payments | $ 100,000,000 | |
Tiered royalties payment term | 10 years | |
Research and development expense | $ 5,400,000 | |
License agreement, contingent consideration liability | 0 | |
Accrued legal fees | 500,000 | |
Legal fees | 200,000 | $ 300,000 |
First Achievement of Annual Global Net Sales of $100.0 Million [Member] | ||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||
Global net sales target amount | 100,000,000 | |
First Achievement of Annual Global Net Sales of $300.0 Million [Member] | ||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||
Global net sales target amount | 300,000,000 | |
First Achievement of Annual Global Net Sales of $500.0 Million [Member] | ||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||
Global net sales target amount | $ 500,000,000 |
Fair Value Measurements - Summa
Fair Value Measurements - Summary of Fair Value of Financial Instruments (Detail) - USD ($) $ in Thousands | Mar. 31, 2020 | Dec. 31, 2019 |
Short-term investments: | ||
Short-term investments | $ 70,472 | $ 71,957 |
U.S. Government Securities [Member] | ||
Short-term investments: | ||
Short-term investments | 15,745 | 15,638 |
Asset Backed Securities [Member] | ||
Short-term investments: | ||
Short-term investments | 3,027 | 8,799 |
Corporate Securities [Member] | ||
Short-term investments: | ||
Short-term investments | 25,339 | 30,585 |
Commercial Paper [Member] | ||
Short-term investments: | ||
Short-term investments | 26,361 | 16,935 |
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 | 30,268 | 13,530 |
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 | 15,745 | 15,638 |
Fair Value, Measurements, Recurring [Member] | Significant Other Observable Inputs (Level 2) [Member] | ||
Other liabilities: | ||
Foreign exchange derivatives not designated as hedging instruments | 88 | |
Other assets: | ||
Foreign exchange derivatives not designated as hedging instruments | 7 | |
Fair Value, Measurements, Recurring [Member] | Significant Other Observable Inputs (Level 2) [Member] | Repurchase Agreements [Member] | ||
Cash equivalents: | ||
Cash equivalents | 6,000 | |
Fair Value, Measurements, Recurring [Member] | Significant Other Observable Inputs (Level 2) [Member] | Asset Backed Securities [Member] | ||
Short-term investments: | ||
Short-term investments | 3,027 | 8,799 |
Fair Value, Measurements, Recurring [Member] | Significant Other Observable Inputs (Level 2) [Member] | Corporate Securities [Member] | ||
Short-term investments: | ||
Short-term investments | 25,339 | 30,585 |
Fair Value, Measurements, Recurring [Member] | Significant Other Observable Inputs (Level 2) [Member] | Commercial Paper [Member] | ||
Short-term investments: | ||
Short-term investments | $ 26,361 | $ 16,935 |
Fair Value Measurements - Sum_2
Fair Value Measurements - Summary of Changes in Fair Value of Company's Level 3 Financial Instruments (Detail) - Contingent Consideration [Member] $ in Thousands | 12 Months Ended |
Dec. 31, 2019USD ($) | |
Fair Value Liabilities Measured On Recurring Basis Unobservable Input Reconciliation [Line Items] | |
Beginning balance | $ 12,214 |
Change in fair value | 219 |
Settlement of contingent liability | $ (12,433) |
Fair Value Measurements - Addit
Fair Value Measurements - Additional Information (Detail) - USD ($) | 3 Months Ended | 12 Months Ended |
Mar. 31, 2020 | Dec. 31, 2019 | |
Fair Value Disclosures [Abstract] | ||
Fair value, assets, level 1 to level 2 transfers, amount | $ 0 | $ 0 |
Fair value, assets, level 2 to level 1 transfers, amount | 0 | 0 |
Fair value, assets, transfers into level 3, amount | 0 | 0 |
Fair value, assets, transfers out of level 3, amount | $ 0 | $ 0 |
Derivative Financial Instrume_2
Derivative Financial Instruments - Additional Information (Detail) $ in Millions | Mar. 31, 2020USD ($) |
Accrued Expenses and Other Current Liabilities [Member] | |
Derivative [Line Items] | |
Derivative financial instruments estimated fair value | $ 0.1 |
Forward Exchange Contracts [Member] | |
Derivative [Line Items] | |
Unsettled forward exchange contracts to purchase foreign currency | 6 |
Derivative liabilities, fair value | $ 6 |
Shareholders' Equity - Addition
Shareholders' Equity - Additional Information (Detail) - USD ($) $ / shares in Units, $ in Millions | Jul. 12, 2018 | Mar. 31, 2020 | Dec. 31, 2019 | Apr. 28, 2017 |
Class of Warrant or Right [Line Items] | ||||
Common stock, par value | $ 0.001 | $ 0.001 | ||
Common and preferred stock, shares authorized | 201,000,000 | |||
Common stock, shares authorized | 200,000,000 | 200,000,000 | ||
Preferred stock, shares authorized | 1,000,000 | |||
Preferred stock, par value | $ 0.001 | |||
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 | 0 | |||
H.C. Wainwright & Co., LLC [Member] | Common Stock [Member] | ||||
Class of Warrant or Right [Line Items] | ||||
Value of shares sold prior to amendment | $ 2.3 | |||
H.C. Wainwright & Co., LLC [Member] | Maximum [Member] | ||||
Class of Warrant or Right [Line Items] | ||||
Amount available to sell under equity program | $ 60 |
Shareholders' Equity - Summary
Shareholders' Equity - Summary of Company's Common Stock (Detail) - shares | Mar. 31, 2020 | Dec. 31, 2019 |
Equity [Abstract] | ||
Common stock authorized | 200,000,000 | 200,000,000 |
Common stock outstanding | 50,844,504 | 50,790,441 |
Shareholders' Equity - Company'
Shareholders' Equity - Company's Shares of Common Stock Reserved for Issuance (Detail) - shares | Mar. 31, 2020 | Dec. 31, 2019 |
Class of Warrant or Right [Line Items] | ||
Total shares reserved | 44,463,687 | 44,544,392 |
Warrants Acquired in Merger [Member] | ||
Class of Warrant or Right [Line Items] | ||
Total shares reserved | 403,927 | 403,927 |
Warrants Converted In Connection With Merger [Member] | ||
Class of Warrant or Right [Line Items] | ||
Total shares reserved | 72,869 | 72,869 |
April 2017 Warrants [Member] | ||
Class of Warrant or Right [Line Items] | ||
Total shares reserved | 24,725 | 24,725 |
June 2017 Warrants [Member] | ||
Class of Warrant or Right [Line Items] | ||
Total shares reserved | 41,736 | 41,736 |
December 2018 Warrants [Member] | ||
Class of Warrant or Right [Line Items] | ||
Total shares reserved | 11,332 | 11,332 |
2017 Pre-Funded Warrants [Member] | ||
Class of Warrant or Right [Line Items] | ||
Total shares reserved | 775,000 | 775,000 |
Pre-Funded PIPE Warrants [Member] | ||
Class of Warrant or Right [Line Items] | ||
Total shares reserved | 5,780,537 | 5,780,537 |
Milestone Warrants [Member] | ||
Class of Warrant or Right [Line Items] | ||
Total shares reserved | 32,577,209 | 32,577,209 |
Stock Options Outstanding [Member] | ||
Class of Warrant or Right [Line Items] | ||
Total shares reserved | 4,473,477 | 4,541,432 |
Issued and nonvested RSUs [Member] | ||
Class of Warrant or Right [Line Items] | ||
Total shares reserved | 302,875 | 315,625 |
Shareholders' Equity - Summar_2
Shareholders' Equity - Summary of Outstanding Warrants for Company's Common Stock (Detail) | 3 Months Ended |
Mar. 31, 2020$ / sharesshares | |
Class of Warrant or Right [Line Items] | |
Shares Underlying Outstanding Warrants | 39,687,335 |
Exercise Price One [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 Two [Member] | |
Class of Warrant or Right [Line Items] | |
Shares Underlying Outstanding Warrants | 72,869 |
Exercise Price | $ / shares | $ 8.98 |
Expiration Date | 2021-06 |
Exercise Price Three [Member] | |
Class of Warrant or Right [Line Items] | |
Shares Underlying Outstanding Warrants | 775,000 |
Exercise Price | $ / shares | $ 0.01 |
Expiration Date | 2024-10 |
Exercise Price Four [Member] | |
Class of Warrant or Right [Line Items] | |
Shares Underlying Outstanding Warrants | 24,725 |
Exercise Price | $ / shares | $ 2.87 |
Expiration Date | 2027-04 |
Exercise Price Five [Member] | |
Class of Warrant or Right [Line Items] | |
Shares Underlying Outstanding Warrants | 41,736 |
Exercise Price | $ / shares | $ 2.87 |
Expiration Date | 2027-06 |
Exercise Price Six [Member] | |
Class of Warrant or Right [Line Items] | |
Shares Underlying Outstanding Warrants | 11,332 |
Exercise Price | $ / shares | $ 2.87 |
Expiration Date | 2028-12 |
Exercise Price Seven [Member] | |
Class of Warrant or Right [Line Items] | |
Shares Underlying Outstanding Warrants | 5,780,537 |
Exercise Price | $ / shares | $ 0.001 |
Expiration Date | None |
Exercise Price Eight [Member] | |
Class of Warrant or Right [Line Items] | |
Shares Underlying Outstanding Warrants | 32,577,209 |
Exercise Price | $ / shares | $ 1.48 |
Expiration Date | December 2021 or 30 days after clinical milestone |
Commitments - Additional Inform
Commitments - Additional Information (Detail) $ in Thousands | Nov. 29, 2017USD ($) | Mar. 23, 2017ft² | Mar. 31, 2020USD ($) | Dec. 31, 2019USD ($) |
Commitments And Contingencies Disclosure [Abstract] | ||||
Lease commencement date | Jan. 1, 2018 | Jul. 1, 2017 | Nov. 1, 2018 | |
Lease expiration date | Jul. 31, 2021 | May 31, 2020 | Sep. 30, 2022 | |
Annual rental payments | $ 200 | $ 100 | ||
Percentage of lease increase | 2.00% | |||
Lease office space | ft² | 13,707 | |||
Lease agreement date | Jun. 19, 2014 | |||
Annual sublease rental payments | $ 500 | |||
Operating lease, right-of -use asset | $ 500 | |||
Operating Lease, Right-of-Use Asset, Statement of Financial Position [Extensible List] | us-gaap:OtherAssetsNoncurrent | |||
Operating lease, liability | $ 503 | |||
Operating lease, liability, current portion | $ 300 | |||
Operating Lease, Liability, Current, Statement of Financial Position [Extensible List] | us-gaap:AccruedLiabilitiesCurrent | |||
Operating lease, liability, non-current portion | $ 200 | |||
Operating Lease, Liability, Noncurrent, Statement of Financial Position [Extensible List] | us-gaap:OtherLiabilitiesNoncurrent | |||
Employment agreement description | Upon termination without cause, and not as a result of death or disability or resignation for good reason, each of such officers is entitled to receive a payment of base salary for twelve months and a pro-rated portion of their unpaid bonus following termination of employment, and such officer will be entitled to continue to receive coverage under medical and dental benefit plans for twelve months or until such officer is covered under a separate plan from another employer. Upon a termination other than for cause or resignation for good reason within twelve months following a change in control, each of such officers is entitled to receive a payment of base salary for eighteen months and one-hundred percent of their unpaid bonus following termination of employment and such officer will be entitled to continue to receive coverage under medical and dental benefit plans for twelve months or until such officer is covered under a separate plan from another employer and will also be entitled to certain acceleration of such officer’s outstanding nonvested options at the time of such termination. | |||
Percentage of unpaid bonus to be paid upon termination other than for cause or for good reason | 100.00% |
Commitments - Schedule of Matur
Commitments - Schedule of Maturity Analysis of Annual Undiscounted Cash Flows Reconciled to Carrying Value of Operating Lease Liabilities (Detail) $ in Thousands | Mar. 31, 2020USD ($) |
Commitments And Contingencies Disclosure [Abstract] | |
2020 | $ 276 |
2021 | 183 |
2022 | 67 |
Total future minimum lease payments | 526 |
Less imputed interest | (23) |
Operating lease, liability | $ 503 |
Commitments - Schedule of Lease
Commitments - Schedule of Lease Cost and Other Information (Detail) $ in Thousands | 3 Months Ended |
Mar. 31, 2020USD ($) | |
Lease cost: | |
Operating lease cost | $ 385 |
Sublease income | (136) |
Total lease cost | 249 |
Other information: | |
Operating cash flows from operating leases | $ 200 |
Weighted-average remaining lease term (in months) - operating leases | 18 years 10 months 24 days |
Weighted-average discount rate - operating leases | 8.50% |
Stock-Based Compensation - Addi
Stock-Based Compensation - Additional Information (Detail) | 3 Months Ended |
Mar. 31, 2020shares | |
2008 Stock Option Plan [Member] | Stock Options [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 |
2008 Stock Option Plan [Member] | Tranche One [Member] | Stock Options [Member] | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |
Vesting period | 3 years |
2008 Stock Option Plan [Member] | Tranche Two [Member] | Stock Options [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 | 298,853 |
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 Stock-based Awards for 2008 Plan and 2015 Plan (Detail) - 2008 Plan and 2015 Plan [Member] - shares | 3 Months Ended | |
Mar. 31, 2020 | Mar. 31, 2019 | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Stock Options, Outstanding at beginning balance | 4,541,432 | 3,077,264 |
Stock Options, Granted | 12,000 | 90,000 |
Stock Options, Exercised | (41,313) | (23,593) |
Stock Options, Forfeited | (38,642) | (9,844) |
Stock Options, Outstanding at ending balance | 4,473,477 | 3,133,827 |
RSUs, Outstanding at beginning balance | 315,625 | 156,250 |
RSUs, Exercised | (12,750) | (13,125) |
RSUs, Outstanding at ending balance | 302,875 | 143,125 |
Total, Outstanding at beginning balance | 4,857,057 | 3,233,514 |
Total, Granted | 12,000 | 90,000 |
Total, Exercised | (54,063) | (36,718) |
Total, Forfeited | (38,642) | (9,844) |
Total, Outstanding at ending balance | 4,776,352 | 3,276,952 |
Stock-Based Compensation - Stoc
Stock-Based Compensation - Stock-based Compensation Expense included in Accompanying Statements of Operations and Comprehensive Loss (Detail) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2020 | Mar. 31, 2019 | |
Employee Service Share Based Compensation Allocation Of Recognized Period Costs [Line Items] | ||
Total stock-based compensation | $ 1,194 | $ 1,000 |
Research and Development [Member] | ||
Employee Service Share Based Compensation Allocation Of Recognized Period Costs [Line Items] | ||
Total stock-based compensation | 593 | 452 |
General and Administrative [Member] | ||
Employee Service Share Based Compensation Allocation Of Recognized Period Costs [Line Items] | ||
Total stock-based compensation | $ 601 | $ 548 |
Net Loss Per Share - Schedule o
Net Loss Per Share - Schedule of Anti-dilutive Weighted-Average Equity Instruments Excluded from Calculation of Diluted Net Loss Per Share (Detail) - shares | 3 Months Ended | |
Mar. 31, 2020 | Mar. 31, 2019 | |
Earnings Per Share Basic [Line Items] | ||
Anti-dilutive securities excluded from calculation of diluted net loss per share | 37,908,150 | 4,178,454 |
Awards under Equity Incentive Plan [Member] | ||
Earnings Per Share Basic [Line Items] | ||
Anti-dilutive securities excluded from calculation of diluted net loss per share | 4,473,477 | 3,133,827 |
Nonvested Restricted Shares and Restricted Stock Units [Member] | ||
Earnings Per Share Basic [Line Items] | ||
Anti-dilutive securities excluded from calculation of diluted net loss per share | 302,875 | 143,125 |
Warrants to Purchase Common Stock [Member] | ||
Earnings Per Share Basic [Line Items] | ||
Anti-dilutive securities excluded from calculation of diluted net loss per share | 33,131,798 | 901,502 |
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 | |
Mar. 31, 2020 | Mar. 31, 2019 | |
Earnings Per Share [Abstract] | ||
Net loss | $ (15,421) | $ (12,112) |
Net loss attributable to common stockholders | (15,421) | (12,112) |
Undistributed earnings and net loss attributable to common stockholders, basic and diluted | $ (15,421) | $ (12,112) |
Weighted average common shares outstanding, basic and diluted | 57,364,265 | 36,016,406 |
Basic and diluted EPS | $ (0.27) | $ (0.34) |
Net Loss Per Share - Additional
Net Loss Per Share - Additional Information (Detail) shares in Millions | 3 Months Ended |
Mar. 31, 2020shares | |
Earnings Per Share [Abstract] | |
Shares included in outstanding basic and diluted, issuable to licensor | 1 |