Document and Entity Information
Document and Entity Information - shares | 6 Months Ended | |
Jun. 30, 2021 | Aug. 12, 2021 | |
Document Information [Line Items] | ||
Document Type | 10-Q | |
Amendment Flag | false | |
Document Period End Date | Jun. 30, 2021 | |
Document Fiscal Year Focus | 2021 | |
Document Fiscal Period Focus | Q2 | |
Entity Registrant Name | Savara Inc. | |
Entity Central Index Key | 0001160308 | |
Entity Interactive Data Current | Yes | |
Current Fiscal Year End Date | --12-31 | |
Entity Filer Category | Non-accelerated Filer | |
Entity Small Business | true | |
Entity Emerging Growth Company | false | |
Entity Common Stock, Shares Outstanding | 113,847,782 | |
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 201 | |
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 $0.001 per share | |
Trading Symbol | SVRA | |
Security Exchange Name | NASDAQ | |
Former Address [Member] | ||
Document Information [Line Items] | ||
Entity Address, Address Line One | 6836 Bee Cave Road | |
Entity Address, Address Line Two | Building III | |
Entity Address, Address Line Three | Suite 200 | |
Entity Address, City or Town | Austin | |
Entity Address, State or Province | TX |
Condensed Consolidated Balance
Condensed Consolidated Balance Sheets (Unaudited) - USD ($) $ in Thousands | Jun. 30, 2021 | Dec. 31, 2020 |
Current assets: | ||
Cash and cash equivalents | $ 40,653 | $ 22,880 |
Short-term investments | 140,018 | 59,308 |
Prepaid expenses and other current assets | 2,817 | 2,933 |
Total current assets | 183,488 | 85,121 |
Property and equipment, net | 102 | 156 |
In-process R&D | 11,834 | 12,218 |
Other non-current assets | 1,009 | 250 |
Total assets | 196,433 | 97,745 |
Current liabilities: | ||
Accounts payable | 2,144 | 2,595 |
Accrued expenses and other current liabilities | 3,491 | 5,579 |
Total current liabilities | 5,635 | 8,174 |
Long-term liabilities: | ||
Debt facility | 25,381 | 25,104 |
Other long-term liabilities | 35 | 84 |
Total liabilities | 31,051 | 33,362 |
Commitments and Contingencies (Note 11) | ||
Stockholders’ equity: | ||
Common stock, $0.001 par value, 300,000,000 and 200,000,000 shares authorized as of June 30, 2021 and December 31, 2020, respectively; 113,847,532 and 54,152,955 shares issued and outstanding as of June 30, 2021 and December 31, 2020, respectively | 114 | 55 |
Additional paid-in capital | 443,341 | 320,893 |
Accumulated other comprehensive income | 592 | 942 |
Accumulated deficit | (278,665) | (257,507) |
Total stockholders’ equity | 165,382 | 64,383 |
Total liabilities and stockholders’ equity | $ 196,433 | $ 97,745 |
Condensed Consolidated Balanc_2
Condensed Consolidated Balance Sheets (Unaudited) (Parenthetical) - $ / shares | Jun. 30, 2021 | Dec. 31, 2020 |
Statement Of Financial Position [Abstract] | ||
Common stock, par value | $ 0.001 | $ 0.001 |
Common stock, shares authorized | 300,000,000 | 200,000,000 |
Common stock, shares issued | 113,847,532 | 54,152,955 |
Common stock, shares outstanding | 113,847,532 | 54,152,955 |
Condensed Consolidated Statemen
Condensed Consolidated Statements of Operations and Comprehensive Loss (Unaudited) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2021 | Jun. 30, 2020 | Jun. 30, 2021 | Jun. 30, 2020 | |
Operating expenses: | ||||
Research and development | $ 7,252 | $ 6,079 | $ 14,841 | $ 19,279 |
General and administrative | 3,153 | 3,117 | 5,931 | 6,099 |
Depreciation and amortization | 47 | 68 | 94 | 126 |
Total operating expenses | 10,452 | 9,264 | 20,866 | 25,504 |
Loss from operations | (10,452) | (9,264) | (20,866) | (25,504) |
Other income, net: | ||||
Interest expense, net | (558) | (332) | (1,150) | (493) |
Foreign currency exchange gain (loss) | 43 | 50 | (15) | 206 |
Tax credit income | 26 | 103 | 873 | 924 |
Change in fair value of financial instruments | 54 | 56 | ||
Total other (loss) income, net | (489) | (125) | (292) | 693 |
Net loss | $ (10,941) | $ (9,389) | $ (21,158) | $ (24,811) |
Net loss per share: | ||||
Basic and diluted | $ (0.07) | $ (0.16) | $ (0.18) | $ (0.43) |
Weighted-average common shares outstanding: | ||||
Basic and diluted | 152,460,531 | 58,858,216 | 114,934,938 | 58,111,225 |
Other comprehensive loss: | ||||
Gain (loss) on foreign currency translation | $ 83 | $ 162 | $ (348) | $ 34 |
Unrealized gain (loss) on short-term investments | 24 | 85 | (2) | 102 |
Total comprehensive loss | $ (10,834) | $ (9,142) | $ (21,508) | $ (24,675) |
Condensed Consolidated Statem_2
Condensed 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, 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 (loss) on short-term investments | 17 | 17 | ||||
Net loss | (15,421) | (15,421) | ||||
Balance on March 31, 2021 at Mar. 31, 2020 | 87,316 | $ 52 | 310,705 | (223,313) | (128) | |
Ending balance, shares at Mar. 31, 2020 | 50,844,504 | |||||
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 | 25,500 | |||||
Issuance of common stock upon exercise of stock options, shares | 64,546 | |||||
Foreign exchange translation adjustment | $ 34 | |||||
Unrealized gain (loss) on short-term investments | 102 | |||||
Net loss | (24,811) | |||||
Balance on March 31, 2021 at Jun. 30, 2020 | 83,798 | $ 54 | 316,327 | (232,702) | 119 | |
Ending balance, shares at Jun. 30, 2020 | 52,823,312 | |||||
Beginning balances at Mar. 31, 2020 | 87,316 | $ 52 | 310,705 | (223,313) | (128) | |
Beginning balance, shares at Mar. 31, 2020 | 50,844,504 | |||||
Issuance of common stock for licensing of assets | 2,120 | $ 1 | 2,119 | |||
Issuance of common stock for licensing of assets, shares | 1,000,000 | |||||
Issuance of common stock upon at the market offerings, net | 2,290 | $ 1 | 2,289 | |||
Issuance of common stock upon at The market offering, net, shares | 942,825 | |||||
Issuance of common stock for settlement of RSUs, shares | 12,750 | |||||
Issuance of common stock upon exercise of stock options | 39 | 39 | ||||
Issuance of common stock upon exercise of stock options, shares | 23,233 | |||||
Stock-based compensation | 1,175 | 1,175 | ||||
Foreign exchange translation adjustment | 162 | 162 | ||||
Unrealized gain (loss) on short-term investments | 85 | 85 | ||||
Net loss | (9,389) | (9,389) | ||||
Balance on March 31, 2021 at Jun. 30, 2020 | 83,798 | $ 54 | 316,327 | (232,702) | 119 | |
Ending balance, shares at Jun. 30, 2020 | 52,823,312 | |||||
Beginning balances at Dec. 31, 2020 | 64,383 | $ 55 | 320,893 | (257,507) | 942 | |
Beginning balance, shares at Dec. 31, 2020 | 54,152,955 | |||||
Issuance of common stock and pre-funded warrants in public offering, net of offering costs | [1] | 121,827 | $ 57 | 121,770 | ||
Issuance of common stock and pre-funded warrants, shares | [1] | 57,479,978 | ||||
Repurchase of outstanding pre-funded warrants | (3,909) | (3,909) | ||||
Net issuance of common stock upon exercise of stock warrants, net | 2,546 | $ 2 | 2,544 | |||
Net issuance of common stock upon exercise of stock warrants, net, shares | 1,737,450 | |||||
Issuance of common stock for settlement of RSUs, shares | 5,563 | |||||
Issuance of common stock upon exercise of stock options | 2 | 2 | ||||
Issuance of common stock upon exercise of stock options, shares | 202,708 | |||||
Stock-based compensation | 946 | 946 | ||||
Foreign exchange translation adjustment | (431) | (431) | ||||
Unrealized gain (loss) on short-term investments | (26) | (26) | ||||
Net loss | (10,217) | (10,217) | ||||
Balance on March 31, 2021 at Mar. 31, 2021 | 175,121 | $ 114 | 442,246 | (267,724) | 485 | |
Ending balance, shares at Mar. 31, 2021 | 113,578,654 | |||||
Beginning balances at Dec. 31, 2020 | $ 64,383 | $ 55 | 320,893 | (257,507) | 942 | |
Beginning balance, shares at Dec. 31, 2020 | 54,152,955 | |||||
Issuance of common stock for settlement of RSUs, shares | 209,250 | |||||
Issuance of common stock upon exercise of stock options, shares | 705,908 | |||||
Foreign exchange translation adjustment | $ (348) | |||||
Unrealized gain (loss) on short-term investments | (2) | |||||
Net loss | (21,158) | |||||
Balance on March 31, 2021 at Jun. 30, 2021 | 165,382 | $ 114 | 443,341 | (278,665) | 592 | |
Ending balance, shares at Jun. 30, 2021 | 113,847,532 | |||||
Beginning balances at Mar. 31, 2021 | 175,121 | $ 114 | 442,246 | (267,724) | 485 | |
Beginning balance, shares at Mar. 31, 2021 | 113,578,654 | |||||
Issuance of common stock and pre-funded warrants in public offering, net of offering costs | 321 | 321 | ||||
Issuance of common stock for settlement of RSUs, shares | 203,687 | |||||
Issuance of common stock upon exercise of stock options | 3 | 3 | ||||
Issuance of common stock upon exercise of stock options, shares | 65,191 | |||||
Stock-based compensation | 771 | 771 | ||||
Foreign exchange translation adjustment | 83 | 83 | ||||
Unrealized gain (loss) on short-term investments | 24 | 24 | ||||
Net loss | (10,941) | (10,941) | ||||
Balance on March 31, 2021 at Jun. 30, 2021 | $ 165,382 | $ 114 | $ 443,341 | $ (278,665) | $ 592 | |
Ending balance, shares at Jun. 30, 2021 | 113,847,532 | |||||
[1] | As discussed in Note 10. Stockholders’ Equity , |
Condensed Consolidated Statem_3
Condensed Consolidated Statements of Changes in Stockholders' Equity (Unaudited) (Parenthetical) - $ / shares | Mar. 15, 2021 | Jun. 30, 2021 | Dec. 31, 2020 |
Common stock, par value | $ 0.001 | $ 0.001 | |
Public Offering of Common Stock [Member] | |||
Common stock, shares sold | 57,479,978 | ||
Common stock, par value | $ 0.001 | ||
Common stock, pre-funded warrants to purchase | 32,175,172 | ||
Common Stock pre funded warrants exercise price | $ 0.001 |
Condensed Consolidated Statem_4
Condensed Consolidated Statements of Cash Flows (Unaudited) - USD ($) $ in Thousands | 6 Months Ended | |
Jun. 30, 2021 | Jun. 30, 2020 | |
Cash flows from operating activities: | ||
Net loss | $ (21,158) | $ (24,811) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Depreciation and amortization | 94 | 126 |
Amortization of right-of-use assets | 116 | 329 |
Acquired in-process research and development (Note 7) | 5,367 | |
Changes in fair value of financial instruments | (56) | |
Noncash interest expense | 143 | |
Foreign currency loss (gain) | 15 | (206) |
Amortization of debt issuance costs | 277 | 259 |
Amortization (accretion) on premium or discount to short-term investments | 668 | (113) |
Stock-based compensation | 1,717 | 2,369 |
Changes in operating assets and liabilities: | ||
Prepaid expenses and other current assets | (170) | (583) |
Non-current assets | (890) | (812) |
Accounts payable and accrued expenses and other current liabilities | (2,413) | (2,376) |
Long-term liabilities | (47) | (467) |
Net cash used in operating activities | (21,791) | (20,831) |
Cash flows from investing activities: | ||
Purchase of property and equipment | (6) | (24) |
Purchase of in-process research and development (Note 7) | (3,247) | |
Purchase of available-for-sale securities, net | (114,445) | (35,614) |
Maturities of available-for-sale securities | 33,280 | 46,400 |
Sale of available-for-sale securities, net | 8,780 | |
Net cash (used in) provided by investing activities | (81,171) | 16,295 |
Cash flows from financing activities: | ||
Repurchase of outstanding pre-funded warrants | (3,909) | |
Repayment of debt facility | (514) | |
Issuance of common stock and pre-funded warrants in public offering, net of offering costs | 122,148 | |
Issuance of common stock upon at the market offerings, net | 2,290 | |
Proceeds from exercise of stock options | 5 | 86 |
Issuance of common stock upon exercise of warrants, net | 2,546 | |
Net cash provided by financing activities | 120,790 | 1,862 |
Effect of exchange rate changes on cash and cash equivalents | (55) | (13) |
Increase (decrease) in cash and cash equivalents | 17,773 | (2,687) |
Cash and cash equivalents beginning of period | 22,880 | 49,804 |
Cash and cash equivalents end of period | 40,653 | 47,117 |
Non-cash transactions | ||
Common stock issued for acquired in-process research and development (Note 7) | (2,120) | |
Supplemental disclosure of cash flow information: | ||
Cash paid for interest, including end of period charge due upon debt facility amendment | $ 974 | $ 1,485 |
Organization and Nature of Oper
Organization and Nature of Operations | 6 Months Ended |
Jun. 30, 2021 | |
Organization Consolidation And Presentation Of Financial Statements [Abstract] | |
Organization and Nature of Operations | 1. Organization and Nature of Operations Description of Business Savara Inc. (together with its subsidiaries “Savara,” the “Company,” “we” or “us”) is a clinical stage company focused on rare respiratory diseases. The Company’s lead program, molgramostim nebulizer solution (“molgramostim”), is an inhaled granulocyte-macrophage colony-stimulating factor in Phase 3 development for autoimmune pulmonary alveolar proteinosis (“aPAP”). Previously, the Company’s pipeline included vancomycin hydrochloride inhalation powder (“vancomycin”) for persistent methicillin-resistant Staphylococcus aureus 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. |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 6 Months Ended |
Jun. 30, 2021 | |
Accounting Policies [Abstract] | |
Summary of Significant Accounting Policies | 2. Summary of Significant Accounting Policies 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”). The unaudited condensed consolidated financial statements have been prepared on the same basis as the annual consolidated financial statements and reflect, in the opinion of management, all adjustments that are necessary to fairly present the statements of financial position, operations and cash flows for the periods presented. 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, 2021 or for any other future annual or interim period. Certain information and footnote disclosures normally included in annual financial statements prepared in accordance with U.S. GAAP have been omitted from these condensed consolidated financial statements, as permitted by rules and regulations of the U.S. Securities and Exchange Commission (the “SEC”). The Company believes the disclosures made in these condensed consolidated financial statements are adequate to make the information herein not misleading. The Company recommends that these condensed consolidated financial statements be read in conjunction with its audited consolidated financial statements and related notes thereto included in the Annual Report on Form 10-K for the year ended December 31, 2020. The Company’s significant accounting policies are described in Note 2 to the audited consolidated financial statements. There have been no changes to our significant accounting policies since the date of those financial statements. Certain prior period amounts have been reclassified for consistency with current period presentation. Principles of Consolidation The interim condensed consolidated financial statements of the Company are stated in U.S. dollars and are prepared under U.S. GAAP. These condensed consolidated 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 Liquidity As of June 30, 2021, the Company had an accumulated deficit of approximately $278.7 million. The Company used cash in operating activities of approximately $21.8 million during the six months ended June 30, 2021. 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. Although the Company has sufficient capital to fund many of its planned activities, it may need to continue to raise additional capital to further fund the development of, and seek regulatory approvals for, its product candidate and begin to commercialize any approved product. The Company is currently focused on the development of molgramostim and believes such activities will result in the continued incurrence of significant research and development and other expenses related to this program. If the clinical trial for the Company’s product candidate fails or produces unsuccessful results and the product candidate does not gain regulatory approval or, if approved, fails 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. cannot be sure that additional financing will be available when needed or that, if available, financing will be obtained on terms favorable to the Company or its stockholders. The Company’s cash and cash equivalents of $40.7 million and short-term investments of $140.0 million as of June 30, 2021 are sufficient to fund the Company’s operations for the twelve months subsequent to the issuance date of these condensed consolidated financial statements. The Company may 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 additional financing is not available timely and at adequate levels, the Company will need to reevaluate its long-term operating plans. The condensed consolidated financial statements do not include any adjustments that might result from the outcome of this uncertainty. Use of Estimates The preparation of condensed consolidated financial statements in conformity with U.S. GAAP requires the Company to make certain estimates and assumptions that affect the amounts reported in the condensed consolidated 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 candidate being developed by the Company requires approval 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 candidate will receive the necessary approvals. If the Company is denied regulatory approval of its product candidate, 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. 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 instruments. 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. 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. Recent Accounting Pronouncements Recently Adopted Accounting Pronouncements In December 2019, the FASB issued ASU 2019-12, Income Taxes (Topic 740): Simplifying the Accounting for Income Taxes In August 2020, the FASB issued ASU 2020-06, Debt—Debt with Conversion and Other Options (Subtopic 470-20) and Derivatives and Hedging—Contracts in Entity’s Own Equity (Subtopic 815-40) Recently Issued but not yet Adopted Accounting Pronouncements There are no recent accounting pronouncements issued by the FASB, the AICPA, or the SEC that are believed by management to have a material effect, if any, on the Company’s condensed consolidated financial statements. |
Prepaid Expenses and Other Curr
Prepaid Expenses and Other Current Assets | 6 Months Ended |
Jun. 30, 2021 | |
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): June 30, 2021 December 31, 2020 R&D tax credit receivable $ 1,009 $ 1,042 Prepaid contracted research and development costs 792 591 VAT receivable 453 653 Prepaid insurance 375 453 Deposits and other 188 194 Total prepaid expenses and other current assets $ 2,817 $ 2,933 R&D Tax Credit Receivable The Company has recorded a Danish tax credit earned by its subsidiary, Savara ApS, as of June 30, 2021. 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. During the year ended December 31, 2020, the Company generated a Danish tax credit of $0.9 million which is included in R&D tax credit receivable Other non-current assets The Company also recorded an Australian tax credit 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. During the year ended December 31, 2020, the Company generated an Australian tax credit of $0.1 million which is included in R&D tax credit receivable |
Accrued Expenses and Other Curr
Accrued Expenses and Other Current Liabilities | 6 Months Ended |
Jun. 30, 2021 | |
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): June 30, 2021 December 31, 2020 Accrued contracted research and development costs $ 1,214 $ 2,627 Accrued compensation 1,528 1,920 Accrued general and administrative costs 647 853 Lease liability 102 179 Total accrued expenses and other current liabilities $ 3,491 $ 5,579 Accrued Contracted Research and Development Costs As of June 30, 2021, Accrued contracted research and development Accrued Compensation As of June 30, 2021, Accrued compensation |
Short-term Investments
Short-term Investments | 6 Months Ended |
Jun. 30, 2021 | |
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 June 30, 2021 Amortized Cost Gross Unrealized Gains Gross Unrealized Losses Fair Value Short-term investments U.S. government securities $ 13,151 $ 3 $ — $ 13,154 Asset backed securities 14,013 — (2 ) 14,011 Corporate securities 53,220 2 (5 ) 53,217 Commercial paper 59,636 — — 59,636 Total short-term investments $ 140,020 $ 5 $ (7 ) $ 140,018 As of December 31, 2020 Amortized Cost Gross Unrealized Gains Gross Unrealized Losses Fair Value Short-term investments U.S. government securities $ 13,296 $ 1 $ — $ 13,297 Asset backed securities 2,559 — — 2,559 Corporate securities 19,479 3 (3 ) 19,479 Commercial paper 23,973 — — 23,973 Total short-term investments $ 59,307 $ 4 $ (3 ) $ 59,308 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 There were no significant realized gains or losses related to investments for the six months ended June 30, 2021 and 2020. |
Debt Facility
Debt Facility | 6 Months Ended |
Jun. 30, 2021 | |
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 by the First Amendment to the Loan and Security Agreement on October 31, 2017, the Second Amendment to the Loan and Security Agreement on December 4, 2018 and the Third Amendment on January 31, 2020 (the “Loan Agreement”). The Company executed a fourth amendment (the “Fourth Amendment”) to the Loan Agreement on March 30, 2021. The Fourth Amendment provided that if by June 30, 2021, the Company did not have an ongoing phase 3 clinical trial evaluating its molgramostim product for the treatment of aPAP in which the first patient has been identified and dosed (the “Trial Requirement”), the interest-only period would end and principal plus interest would be due in equal monthly installments over 24 months. The first payment due on July 1, 2021 would include three principal payments. If the Trial Requirement is met, the first payment of principal plus interest would be due on July 1, 2022. Prior to the Fourth Amendment, the interest-only period would end if the Trial Requirement had not been met by March 31, 2021. Additionally, the Fourth Amendment increased the final payment percentage from 6.0% to 6.2%. On June 30, 2021, the Company announced the Trial Requirement had been met. As a result, the interest only-period will continue until June 30, 2022. Silicon Valley Bank has been granted a perfected first priority lien in all of our assets with a negative pledge on our intellectual property. The Loan Agreement, as amended, 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. Additionally, the Loan Agreement, as amended, contains an affirmative covenant requiring us 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, which was satisfied upon completion of the Public Offering, as defined and discussed in Note 10. Stockholders’ Equity . The loan bears 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, also requires a prepayment fee (2.0% of funded amounts in months 13-24, and 1.0% thereafter), and an end of term charge equal to 6.2% of the amount of principal borrowed. 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. Summary of Carrying Value The following table summarizes the components of the debt facility carrying value, which approximates the fair value (in thousands): Future minimum payments due during the year ended December 31, June 30, 2021 December 31, 2020 2021 $ — $ — 2022 8,333 8,333 2023 18,167 18,167 Total future minimum payments 26,500 26,500 Unamortized end of term charge (920 ) (1,134 ) Debt issuance costs (113 ) (149 ) Debt discount related to warrants (86 ) (113 ) Total debt 25,381 25,104 Short-term debt — — Long-term debt $ 25,381 $ 25,104 |
License Agreement
License Agreement | 6 Months Ended |
Jun. 30, 2021 | |
Organization Consolidation And Presentation Of Financial Statements [Abstract] | |
License Agreement | 7. License Agreement Effective March 31, 2020, the Company entered into a license and collaboration agreement (the “License”) that provided Savara an exclusive, worldwide, royalty-bearing license to develop and sell or otherwise commercialize pharmaceutical preparations containing a type of inhaled liposomal ciprofloxacin (“Licensed Product”). During 2020, the Company paid the licensor (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 upon effectiveness of the License (collectively, the “Upfront Payments”). The Company also agreed to pay the licensor (i) certain developmental milestone payments for the development of the Licensed Products upon regulatory approval for commercial sale and (ii) certain sales milestone payments upon the first achievement of defined annual global net sales (collectively, the “Contingent Consideration”). The Company accounted for the License as an asset acquisition in accordance with ASC 805, Business Combinations During December 2020, the Company discontinued further development of the Licensed Product and, as such, determined that payment of the Contingent Consideration is not probable, and therefore, no related liability has been recorded. |
Fair Value Measurements
Fair Value Measurements | 6 Months Ended |
Jun. 30, 2021 | |
Fair Value Disclosures [Abstract] | |
Fair Value Measurements | 8. Fair Value Measurements 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. Assets and Liabilities Measured at Fair Value on a Nonrecurring Basis Certain assets and liabilities are measured at fair value on a nonrecurring basis. These assets and liabilities are not measured at fair value on an ongoing basis, but are subject to fair value adjustments annually or whenever events or circumstances indicate that the carrying value of those assets may not be recoverable. These assets and liabilities can include acquired in-process research and development (“IPR&D”) and other long-lived assets that are written down to fair value if they are impaired. IPR&D is considered an indefinite-lived intangible asset and is assessed for impairment annually , or more frequently if impairment indicators exist. Based upon the ultimate scope and scale of the COVID-19 global pandemic, there may be material negative impacts to the assumptions made with respect to our IPR&D assets that could result in an impairment. For the six months ende d June 3 0 , 2021 and 2020 , the impact of COVID-19 or other factors did not trigger any impairment indicators. During the six months ended June 30, 2021 and 2020, the Company experienced a decrease of approximately $0.4 million and an increase of $0.1 million, respectively, in the carrying value of IPR&D due to foreign currency translation. Assets and Liabilities Measured at Fair Value on a Recurring Basis 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 June 30, 2021 and December 31, 2020 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) Total As of June 30, 2021 Cash equivalents: U.S. Treasury money market funds $ 38,706 $ — $ — $ 38,706 Short-term investments: U.S. government securities 13,154 — — 13,154 Asset backed securities — 14,011 — 14,011 Corporate securities — 53,217 — 53,217 Commercial paper — 59,636 — 59,636 As of December 31, 2020 Cash equivalents: U.S. Treasury money market funds $ 21,872 $ — $ — $ 21,872 Short-term investments: U.S. government securities 13,297 — — 13,297 Asset backed securities — 2,559 — 2,559 Corporate securities — 19,479 — 19,479 Commercial paper — 23,973 — 23,973 |
Derivative Financial Instrument
Derivative Financial Instruments | 6 Months Ended |
Jun. 30, 2021 | |
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. At times, 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 resulting in a minimal net derivative financial instrument, recorded at their estimated fair value in Prepaid expenses and other current assets in the condensed consolidated balance sheet. There were no such derivative contracts as of June 30, 2021. |
Shareholders' Equity
Shareholders' Equity | 6 Months Ended |
Jun. 30, 2021 | |
Equity [Abstract] | |
Shareholders' Equity | 10. Stockholders’ Equity Public Offering of Common Stock On March 15, 2021, the Company sold (i) an aggregate of 57,479,978 shares of the Company’s common stock, par value $0.001 per share (the “Common Stock”) for $1.45 per share, of which 11,694,150 shares were issued pursuant to the underwriters’ option to purchase additional shares, and (ii) pre-funded warrants to purchase an aggregate of 32,175,172 shares of Common Stock at an exercise price of $0.001 per share (the “Pre-Funded Warrants”) for $1.449 per warrant (collectively, the “Public Offering”). The Company determined that the securities issued in the Public Offering were free-standing and that the Pre-Funded Warrants did not contain any settlement obligations that would result in liability classification under ASC 480, Distinguishing Liability from Equity Contracts in Entity’s Own Equity. The Public Offering resulted in net proceeds to the Company of approximately $122.1 million, after deducting final underwriting discounts, commissions and offering expenses, as follows (in thousands): Financial instruments Proceeds Common stock $ 83,346 Pre-funded warrants 46,622 Total 129,968 Offering expenses $ (7,820 ) Net proceeds $ 122,148 The Company intends to use the net proceeds from the Public Offering to fund the clinical trial of molgramostim for the treatment of aPAP and other general corporate purposes. Warrant Repurchase Immediately prior to the Public Offering, the Company entered into separate, privately-negotiated warrant repurchase agreements with certain holders of its outstanding milestone warrants, each dated as of December 24, 2019. The Company paid $3.9 million ($0.15 per share of Common Stock underlying each milestone warrant) to repurchase milestone warrants with 26,061,769 shares of Common Stock underlying such warrants, and the warrants were terminated. Following the warrant repurchase and exercises during the six months ended June 30, 2021, we have outstanding milestone warrants to purchase an aggregate of 3,474,902 shares of our common stock. The warrant repurchase was accounted for as an equity transaction and resulted in a reduction to Additional paid-in capital Termination of 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 on June 29, 2018 (the “Wainwright 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, 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. On July 2, 2021, the Company delivered written notice to Wainwright that it was terminating the Wainwright Sales Agreement effective July 12, 2021. Common Stock Sales Agreement On July 6, 2021, the Company entered into a Common Stock Sales Agreement with Evercore Group L.L.C., (“Evercore”), as sales agent (the “Sales Agreement”), pursuant to which the Company may offer and sell, from time to time, through Evercore, 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. The Agreement was effective on July 1 6 , 2021 , the date the Company’s shelf registration agreement on Form S-3, as filed with the Securities and Exchange Commission on July 6 , 2021, 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, Evercore will use its commercially reasonable efforts to sell the Shares from time to time, based upon the Company’s instructions. The Company has provided Evercore with customary indemnification rights, and Evercore 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 six months ended June 30, 2021, the Company did not sell any common stock under the Wainwright Sales Agreement. During the six months ended June 30, 2020, the Company sold 942,825 shares of common stock under Wainwright Sales Agreement, for net proceeds of approximately $2.3 million. Common Stock Reserved for Issuance The Company’s shares of common stock reserved for issuance as of the periods indicated were as follows: June 30, 2021 December 31, 2020 Warrants acquired in April 2017 merger — 403,927 Warrants converted in connection with April 2017 merger — 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 3,474,902 31,274,121 2021 Pre-funded Warrants 32,175,172 — Stock options outstanding 5,125,189 6,240,342 Issued and nonvested RSUs 357,022 509,397 Total shares reserved 47,765,615 45,133,986 Warrants The following table summarizes the outstanding warrants for the Company’s common stock as of June 30, 2021: Expiration Date Shares Underlying Outstanding Warrants Exercise Price October 2024 775,000 $ 0.01 April 2027 24,725 $ 2.87 June 2027 41,736 $ 2.87 December 2028 11,332 $ 2.87 None 5,780,537 $ 0.001 Earlier of December 2021 or 30 days after clinical milestone 3,474,902 $ 1.48 None 32,175,172 $ 0.001 42,283,404 Accumulated Other Comprehensive Income (Loss) Information The components of accumulated other comprehensive income (loss) as of the dates indicated and the change during the period were (in thousands): Foreign Exchange Translation Adjustment Unrealized Gain (Loss) on ST Investments Total Accumulated Other Comprehensive Income (Loss) Balance, December 31, 2019 $ (65 ) $ 48 $ (17 ) Change 1,006 (47 ) 959 Balance, December 31, 2020 941 1 942 Change (348 ) (2 ) (350 ) Balance, June 30, 2021 $ 593 $ (1 ) $ 592 |
Commitments
Commitments | 6 Months Ended |
Jun. 30, 2021 | |
Commitments And Contingencies Disclosure [Abstract] | |
Commitments | 11. Commitments Manufacturing and Other The Company is subject to various royalties and manufacturing and development payments related to its product candidate, molgramostim. Under a manufacture and supply agreement with the active pharmaceutical ingredients (“API”) manufacturer for molgramostim, 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 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. 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 molgramostim. The decrease in the amount of the milestone payments from December 31, 2020 to June 30, 2021 was primarily related to the removal of approximately $5 million of milestones related to a nebulizer system no longer considered for use. In addition to these milestones, the Company will owe a royalty of three-and one-half percent (3.5%) to the manufacturer of the nebulizer based on net sales. The following table summarizes manufacturing commitments and contingencies as of the period indicated (in thousands): June 30, 2021 Molgramostim manufacturer: Achievement of certain milestones related to validation of API and regulatory approval of molgramostim $ 2,300 Molgramostim nebulizer manufacturer: Achievement of various development activities and regulatory approval of nebulizer utilized to administer molgramostim 607 Total manufacturing and other commitments $ 2,907 The milestone commitments disclosed above reflect the activities that have not been recognized at June 30, 2021 because they are not deemed probable and reasonably estimable. On December 10, 2020, the Company announced that the Phase 3 trial of vancomycin in people living with cystic fibrosis who have MRSA lung infection did not meet the primary endpoint. On January 7, 2021 the Company issued a termination notice to GlaxoSmithKline Trading Services Limited (“GSK”), which manufactures the drug product from bulk vancomycin powder. On January 26, 2021, the Company and GSK entered a change order for termination costs associated with the closeout and wind down of vancomycin activities. During the six months ended June 30, 2021, the Company paid approximately $0.8 million of research and development expense related to the termination of the manufacturing agreement. Contract Research On March 5, 2021, the Company entered into a Master Services Agreement (“MSA”) with Parexel International (IRL) Limited (“Parexel”) pursuant to which Parexel will provide contract research services related to our clinical trials. Contemporaneously with entering the MSA, a work order was executed with Parexel, under which they will provide services related to the IMPALA-2 trial. Under that work order and subsequent change orders, the Company will pay Parexel service fees and pass-through expenses estimated to be approximately $31 million over the course of the IMPALA-2 clinical trial. 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. |
Stock-Based Compensation
Stock-Based Compensation | 6 Months Ended |
Jun. 30, 2021 | |
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 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 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. 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”), as amended and restated with approval by our stockholders in June 2018 and May 2020. 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 June 30, 2021, the number of shares of our common stock available for grant under the 2015 Plan was 2,253,456 shares. Under both the 2008 Plan and 2015 Plan, stock option and restricted stock unit grants typically vest quarterly over four years and expire ten years from the grant date. 2021 Inducement Equity Incentive Plan The Company adopted the 2021 Inducement Equity Incentive Plan (the “Inducement Plan”) with approval by our board of directors in May 2021. The Inducement Plan provides for the grant of non-statutory stock options, restricted stock, restricted stock units, stock appreciation rights, performance units or performance shares. Each award under the Inducement Plan is intended to qualify as an employment inducement grant in accordance with Nasdaq Listing Rule 5635(c)(4). As of June 30, 2021, the number of shares of our common stock available for grant under the 2021 Plan was 425,000 shares. Under the Inducement Plan, stock option grants typically vest quarterly over four years and expire ten years from the grant date and restricted stock unit grants typically cliff vest after two years. B. Stock Option and Restricted Stock Units The Company values stock options using the Black-Scholes-Merton option pricing model, which requires the input of subjective assumptions, including the risk-free interest rate, expected life, expected stock price volatility, and dividend yield. The risk-free interest rate assumption is based upon observed interest rates for constant maturity U.S. Treasury securities consistent with the expected term of the Company’s employee stock options. The expected life represents the period of time the stock options are expected to be outstanding and is based on the simplified method. The Company uses the simplified method due to the lack of sufficient historical exercise data to provide a reasonable basis upon which to otherwise estimate the expected life of the stock options. Expected volatility is based on historical volatilities for publicly traded stock of comparable companies over the estimated expected life of the stock options. The Company assumes no dividend yield because dividends are not expected to be paid in the future, consistent with the Company’s history of not paying dividends. The valuation of stock options is also impacted by the valuation of common stock. Restricted stock units are valued at the closing market price of the Company’s common stock on the date of grant. C. Stock-Based Award Activity The following table provides a summary of stock-based awards activity under the 2008 Plan and 2015 Plan for the six months ended June 30, 2021: Six months ended June 30, 2021 Six months ended June 30, 2020 Stock Options RSUs Total Stock Options RSUs Total Outstanding as of December 31 6,240,343 509,397 6,749,740 4,541,432 315,625 4,857,057 Granted 245,000 100,000 345,000 32,000 — 32,000 Exercised (705,908 ) (209,250 ) (915,158 ) (64,546 ) (25,500 ) (90,046 ) Forfeited (654,246 ) (43,125 ) (697,371 ) (105,094 ) — (105,094 ) Outstanding as of June 30 5,125,189 357,022 5,482,211 4,403,792 290,125 4,693,917 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 and six months ended June 30, 2021 and 2020 (in thousands): Three months ended June 30, Six months ended June 30, 2021 2020 2021 2020 Research and development $ 291 $ 358 $ 755 $ 951 General and administrative 480 817 962 1,418 Total stock-based compensation $ 771 $ 1,175 $ 1,717 $ 2,369 |
Net Loss Per Share
Net Loss Per Share | 6 Months Ended |
Jun. 30, 2021 | |
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 attributable to common stockholders by the weighted-average number of common stock and pre-funded warrants outstanding during the period without consideration of common stock equivalents. 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 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: Six months ended June 30, 2021 2020 Awards under equity incentive plan 5,125,189 4,403,792 Nonvested restricted shares and restricted stock units 357,022 290,125 Warrants to purchase common stock 3,552,695 33,131,798 Total 9,034,906 37,825,715 The following table calculates basic earnings per share of common stock and diluted earnings per share of common stock for the three and six months ended June 30, 2021 and 2020 (in thousands, except share and per share amounts): Three months ended June 30, Six months ended June 30, 2021 2020 2021 2020 Net loss $ (10,941 ) $ (9,389 ) $ (21,158 ) $ (24,811 ) Net loss attributable to common stockholders (10,941 ) (9,389 ) (21,158 ) (24,811 ) Undistributed earnings and net loss attributable to common stockholders, basic and diluted (10,941 ) (9,389 ) (21,158 ) (24,811 ) Weighted average common shares outstanding, basic and diluted 152,460,531 58,858,216 114,934,938 58,111,225 Basic and diluted EPS $ (0.07 ) $ (0.16 ) $ (0.18 ) $ (0.43 ) |
Subsequent Events
Subsequent Events | 6 Months Ended |
Jun. 30, 2021 | |
Subsequent Events [Abstract] | |
Subsequent Events | 14. Subsequent Events The Company has evaluated subsequent events through the date these condensed consolidated financial statements were issued. The Company determined there were no events, other than as described below, that required disclosure or recognition in these condensed consolidated financial statements. Corporate Office Lease The Company is headquartered in Austin, Texas, where it subleased office space pursuant to a sublease that expired at the end of July 2021. On June 3, 2021, the Company entered into a Lease Agreement (the “Lease”) with Overlook at Rob Roy Owner, LLC for a different office suite located in the same building and relocated its headquarters to this location. The lease commencement date is August 1, 2021 and will continue until December 31, 2022. On commencement of the lease, the Company recorded an operating lease liability and corresponding right-of-use asset of approximately $0.1 million. Termination of Common Stock Sales Agreement On July 2, 2021, the Company delivered written notice to Wainwright that it was terminating the Wainwright Sales Agreement effective July 12, 2021. Please refer to Note 10. Stockholders’ Equity for additional discussion. Common Stock Sales Agreement On July 6, 2021, the Company entered into a Common Stock Sales Agreement with Evercore, which was effective on July 16, 2021, the date the Company’s New Registration Statement was declared effective. Please refer to Note 10. Stockholders’ Equity |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Policies) | 6 Months Ended |
Jun. 30, 2021 | |
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”). The unaudited condensed consolidated financial statements have been prepared on the same basis as the annual consolidated financial statements and reflect, in the opinion of management, all adjustments that are necessary to fairly present the statements of financial position, operations and cash flows for the periods presented. 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, 2021 or for any other future annual or interim period. Certain information and footnote disclosures normally included in annual financial statements prepared in accordance with U.S. GAAP have been omitted from these condensed consolidated financial statements, as permitted by rules and regulations of the U.S. Securities and Exchange Commission (the “SEC”). The Company believes the disclosures made in these condensed consolidated financial statements are adequate to make the information herein not misleading. The Company recommends that these condensed consolidated financial statements be read in conjunction with its audited consolidated financial statements and related notes thereto included in the Annual Report on Form 10-K for the year ended December 31, 2020. The Company’s significant accounting policies are described in Note 2 to the audited consolidated financial statements. There have been no changes to our significant accounting policies since the date of those financial statements. Certain prior period amounts have been reclassified for consistency with current period presentation. |
Principles of Consolidation | Principles of Consolidation The interim condensed consolidated financial statements of the Company are stated in U.S. dollars and are prepared under U.S. GAAP. These condensed consolidated 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 |
Liquidity | Liquidity As of June 30, 2021, the Company had an accumulated deficit of approximately $278.7 million. The Company used cash in operating activities of approximately $21.8 million during the six months ended June 30, 2021. 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. Although the Company has sufficient capital to fund many of its planned activities, it may need to continue to raise additional capital to further fund the development of, and seek regulatory approvals for, its product candidate and begin to commercialize any approved product. The Company is currently focused on the development of molgramostim and believes such activities will result in the continued incurrence of significant research and development and other expenses related to this program. If the clinical trial for the Company’s product candidate fails or produces unsuccessful results and the product candidate does not gain regulatory approval or, if approved, fails 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. cannot be sure that additional financing will be available when needed or that, if available, financing will be obtained on terms favorable to the Company or its stockholders. The Company’s cash and cash equivalents of $40.7 million and short-term investments of $140.0 million as of June 30, 2021 are sufficient to fund the Company’s operations for the twelve months subsequent to the issuance date of these condensed consolidated financial statements. The Company may 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 additional financing is not available timely and at adequate levels, the Company will need to reevaluate its long-term operating plans. The condensed consolidated financial statements do not include any adjustments that might result from the outcome of this uncertainty. |
Use of Estimates | Use of Estimates The preparation of condensed consolidated financial statements in conformity with U.S. GAAP requires the Company to make certain estimates and assumptions that affect the amounts reported in the condensed consolidated 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 candidate being developed by the Company requires approval 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 candidate will receive the necessary approvals. If the Company is denied regulatory approval of its product candidate, 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. |
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 instruments. 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. |
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. |
Recent Accounting Pronouncements | Recent Accounting Pronouncements Recently Adopted Accounting Pronouncements In December 2019, the FASB issued ASU 2019-12, Income Taxes (Topic 740): Simplifying the Accounting for Income Taxes In August 2020, the FASB issued ASU 2020-06, Debt—Debt with Conversion and Other Options (Subtopic 470-20) and Derivatives and Hedging—Contracts in Entity’s Own Equity (Subtopic 815-40) Recently Issued but not yet Adopted Accounting Pronouncements There are no recent accounting pronouncements issued by the FASB, the AICPA, or the SEC that are believed by management to have a material effect, if any, on the Company’s condensed consolidated financial statements. |
Prepaid Expenses and Other Cu_2
Prepaid Expenses and Other Current Assets (Tables) | 6 Months Ended |
Jun. 30, 2021 | |
Prepaid Expense And Other Assets Current [Abstract] | |
Schedule of Prepaid Expenses and Other Current Assets | Prepaid expenses consisted of (in thousands): June 30, 2021 December 31, 2020 R&D tax credit receivable $ 1,009 $ 1,042 Prepaid contracted research and development costs 792 591 VAT receivable 453 653 Prepaid insurance 375 453 Deposits and other 188 194 Total prepaid expenses and other current assets $ 2,817 $ 2,933 |
Accrued Expenses and Other Cu_2
Accrued Expenses and Other Current Liabilities (Tables) | 6 Months Ended |
Jun. 30, 2021 | |
Payables And Accruals [Abstract] | |
Summary of Accrued Expenses and Other Current Liabilities | Accrued expenses and other current liabilities consisted of (in thousands): June 30, 2021 December 31, 2020 Accrued contracted research and development costs $ 1,214 $ 2,627 Accrued compensation 1,528 1,920 Accrued general and administrative costs 647 853 Lease liability 102 179 Total accrued expenses and other current liabilities $ 3,491 $ 5,579 |
Short-term Investments (Tables)
Short-term Investments (Tables) | 6 Months Ended |
Jun. 30, 2021 | |
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 June 30, 2021 Amortized Cost Gross Unrealized Gains Gross Unrealized Losses Fair Value Short-term investments U.S. government securities $ 13,151 $ 3 $ — $ 13,154 Asset backed securities 14,013 — (2 ) 14,011 Corporate securities 53,220 2 (5 ) 53,217 Commercial paper 59,636 — — 59,636 Total short-term investments $ 140,020 $ 5 $ (7 ) $ 140,018 As of December 31, 2020 Amortized Cost Gross Unrealized Gains Gross Unrealized Losses Fair Value Short-term investments U.S. government securities $ 13,296 $ 1 $ — $ 13,297 Asset backed securities 2,559 — — 2,559 Corporate securities 19,479 3 (3 ) 19,479 Commercial paper 23,973 — — 23,973 Total short-term investments $ 59,307 $ 4 $ (3 ) $ 59,308 |
Debt Facility (Tables)
Debt Facility (Tables) | 6 Months Ended |
Jun. 30, 2021 | |
Debt Disclosure [Abstract] | |
Carrying Value and Future Minimum Payments | The following table summarizes the components of the debt facility carrying value, which approximates the fair value (in thousands): Future minimum payments due during the year ended December 31, June 30, 2021 December 31, 2020 2021 $ — $ — 2022 8,333 8,333 2023 18,167 18,167 Total future minimum payments 26,500 26,500 Unamortized end of term charge (920 ) (1,134 ) Debt issuance costs (113 ) (149 ) Debt discount related to warrants (86 ) (113 ) Total debt 25,381 25,104 Short-term debt — — Long-term debt $ 25,381 $ 25,104 |
Fair Value Measurements (Tables
Fair Value Measurements (Tables) | 6 Months Ended |
Jun. 30, 2021 | |
Fair Value Disclosures [Abstract] | |
Summary of Fair Value of Financial Instruments | The fair value of these instruments as of June 30, 2021 and December 31, 2020 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) Total As of June 30, 2021 Cash equivalents: U.S. Treasury money market funds $ 38,706 $ — $ — $ 38,706 Short-term investments: U.S. government securities 13,154 — — 13,154 Asset backed securities — 14,011 — 14,011 Corporate securities — 53,217 — 53,217 Commercial paper — 59,636 — 59,636 As of December 31, 2020 Cash equivalents: U.S. Treasury money market funds $ 21,872 $ — $ — $ 21,872 Short-term investments: U.S. government securities 13,297 — — 13,297 Asset backed securities — 2,559 — 2,559 Corporate securities — 19,479 — 19,479 Commercial paper — 23,973 — 23,973 |
Shareholders' Equity (Tables)
Shareholders' Equity (Tables) | 6 Months Ended |
Jun. 30, 2021 | |
Equity [Abstract] | |
Summary of Net Proceeds after Deducting Underwriting Discounts Commissions and Offering Expenses | The Public Offering resulted in net proceeds to the Company of approximately $122.1 million, after deducting final underwriting discounts, commissions and offering expenses, as follows (in thousands): Financial instruments Proceeds Common stock $ 83,346 Pre-funded warrants 46,622 Total 129,968 Offering expenses $ (7,820 ) Net proceeds $ 122,148 |
Company's Shares of Common Stock Reserved for Issuance | The Company’s shares of common stock reserved for issuance as of the periods indicated were as follows: June 30, 2021 December 31, 2020 Warrants acquired in April 2017 merger — 403,927 Warrants converted in connection with April 2017 merger — 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 3,474,902 31,274,121 2021 Pre-funded Warrants 32,175,172 — Stock options outstanding 5,125,189 6,240,342 Issued and nonvested RSUs 357,022 509,397 Total shares reserved 47,765,615 45,133,986 |
Summary of Outstanding Warrants for Company's Common Stock | The following table summarizes the outstanding warrants for the Company’s common stock as of June 30, 2021: Expiration Date Shares Underlying Outstanding Warrants Exercise Price October 2024 775,000 $ 0.01 April 2027 24,725 $ 2.87 June 2027 41,736 $ 2.87 December 2028 11,332 $ 2.87 None 5,780,537 $ 0.001 Earlier of December 2021 or 30 days after clinical milestone 3,474,902 $ 1.48 None 32,175,172 $ 0.001 42,283,404 |
Components of Accumulated Other Comprehensive Income (Loss) | Accumulated Other Comprehensive Income (Loss) Information The components of accumulated other comprehensive income (loss) as of the dates indicated and the change during the period were (in thousands): Foreign Exchange Translation Adjustment Unrealized Gain (Loss) on ST Investments Total Accumulated Other Comprehensive Income (Loss) Balance, December 31, 2019 $ (65 ) $ 48 $ (17 ) Change 1,006 (47 ) 959 Balance, December 31, 2020 941 1 942 Change (348 ) (2 ) (350 ) Balance, June 30, 2021 $ 593 $ (1 ) $ 592 |
Commitments (Tables)
Commitments (Tables) | 6 Months Ended |
Jun. 30, 2021 | |
Commitments And Contingencies Disclosure [Abstract] | |
Schedule of Manufacturing Commitments and Contingencies | The following table summarizes manufacturing commitments and contingencies as of the period indicated (in thousands): June 30, 2021 Molgramostim manufacturer: Achievement of certain milestones related to validation of API and regulatory approval of molgramostim $ 2,300 Molgramostim nebulizer manufacturer: Achievement of various development activities and regulatory approval of nebulizer utilized to administer molgramostim 607 Total manufacturing and other commitments $ 2,907 |
Stock-Based Compensation (Table
Stock-Based Compensation (Tables) | 6 Months Ended |
Jun. 30, 2021 | |
Disclosure Of Compensation Related Costs Sharebased Payments [Abstract] | |
Summary of Stock-based Awards Activity Under the 2008 Plan and 2015 Plan | The following table provides a summary of stock-based awards activity under the 2008 Plan and 2015 Plan for the six months ended June 30, 2021: Six months ended June 30, 2021 Six months ended June 30, 2020 Stock Options RSUs Total Stock Options RSUs Total Outstanding as of December 31 6,240,343 509,397 6,749,740 4,541,432 315,625 4,857,057 Granted 245,000 100,000 345,000 32,000 — 32,000 Exercised (705,908 ) (209,250 ) (915,158 ) (64,546 ) (25,500 ) (90,046 ) Forfeited (654,246 ) (43,125 ) (697,371 ) (105,094 ) — (105,094 ) Outstanding as of June 30 5,125,189 357,022 5,482,211 4,403,792 290,125 4,693,917 |
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 and six months ended June 30, 2021 and 2020 (in thousands): Three months ended June 30, Six months ended June 30, 2021 2020 2021 2020 Research and development $ 291 $ 358 $ 755 $ 951 General and administrative 480 817 962 1,418 Total stock-based compensation $ 771 $ 1,175 $ 1,717 $ 2,369 |
Net Loss Per Share (Tables)
Net Loss Per Share (Tables) | 6 Months Ended |
Jun. 30, 2021 | |
Earnings Per Share [Abstract] | |
Schedule of Anti-dilutive Equity Instruments Excluded from Calculation of Diluted Net Loss Per Share | The following 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: Six months ended June 30, 2021 2020 Awards under equity incentive plan 5,125,189 4,403,792 Nonvested restricted shares and restricted stock units 357,022 290,125 Warrants to purchase common stock 3,552,695 33,131,798 Total 9,034,906 37,825,715 |
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 and six months ended June 30, 2021 and 2020 (in thousands, except share and per share amounts): Three months ended June 30, Six months ended June 30, 2021 2020 2021 2020 Net loss $ (10,941 ) $ (9,389 ) $ (21,158 ) $ (24,811 ) Net loss attributable to common stockholders (10,941 ) (9,389 ) (21,158 ) (24,811 ) Undistributed earnings and net loss attributable to common stockholders, basic and diluted (10,941 ) (9,389 ) (21,158 ) (24,811 ) Weighted average common shares outstanding, basic and diluted 152,460,531 58,858,216 114,934,938 58,111,225 Basic and diluted EPS $ (0.07 ) $ (0.16 ) $ (0.18 ) $ (0.43 ) |
Organization and Nature of Op_2
Organization and Nature of Operations - Additional Information (Detail) | 6 Months Ended |
Jun. 30, 2021USD ($)Segment | |
Organization And Nature Of Operations [Line Items] | |
Number of operating segments | Segment | 1 |
Product [Member] | |
Organization And Nature Of Operations [Line Items] | |
Revenue from inception to date | $ | $ 0 |
Summary of Significant Accoun_3
Summary of Significant Accounting Policies - Additional Information (Detail) $ in Thousands | 6 Months Ended | ||
Jun. 30, 2021USD ($)Segment | Jun. 30, 2020USD ($) | Dec. 31, 2020USD ($) | |
Summary Of Significant Accounting Policies [Line Items] | |||
Accumulated deficit | $ (278,665) | $ (257,507) | |
Cash in operating activities | (21,791) | $ (20,831) | |
Cash and cash equivalents | 40,653 | 22,880 | |
Short-term investments | $ 140,018 | $ 59,308 | |
Number of operating segments | Segment | 1 | ||
ASU 2019-12 [Member] | |||
Summary Of Significant Accounting Policies [Line Items] | |||
Change in accounting principle, accounting standards update, adopted | true | ||
Change in accounting principle, accounting standards update, adoption date | Jan. 1, 2021 | ||
Change in accounting principle, accounting standards update, immaterial effect | true | ||
ASU 2020-06 [Member] | |||
Summary Of Significant Accounting Policies [Line Items] | |||
Change in accounting principle, accounting standards update, early adopted | true | ||
Change in accounting principle, accounting standards update, adoption date | Jan. 1, 2021 | ||
Change in accounting principle, accounting standards update, immaterial effect | true |
Prepaid Expenses and Other Cu_3
Prepaid Expenses and Other Current Assets - Summary of Prepaid Expenses and Other Current Assets (Detail) - USD ($) $ in Thousands | Jun. 30, 2021 | Dec. 31, 2020 |
Prepaid Expense And Other Assets Current [Abstract] | ||
R&D tax credit receivable | $ 1,009 | $ 1,042 |
Prepaid contracted research and development costs | 792 | 591 |
VAT receivable | 453 | 653 |
Prepaid insurance | 375 | 453 |
Deposits and other | 188 | 194 |
Total prepaid expenses and other current assets | $ 2,817 | $ 2,933 |
Prepaid Expenses and Other Cu_4
Prepaid Expenses and Other Current Assets - Additional Information (Detail) - USD ($) $ in Millions | 6 Months Ended | |
Jun. 30, 2021 | Dec. 31, 2020 | |
Savara ApS [Member] | ||
Prepaid Expenses And Other Current Assets [Line Items] | ||
Research and development tax credits | 22.00% | |
Savara ApS [Member] | R&D Tax Credit Receivable [Member] | ||
Prepaid Expenses And Other Current Assets [Line Items] | ||
Research and development tax credits receivable | $ 0.9 | |
Savara ApS [Member] | Other Non-current Assets [Member] | ||
Prepaid Expenses And Other Current Assets [Line Items] | ||
Research and development tax credits receivable | $ 0.9 | |
Savara Australia Pty Limited [Member] | ||
Prepaid Expenses And Other Current Assets [Line Items] | ||
Research and development tax credits | 43.50% | |
Savara Australia Pty Limited [Member] | R&D Tax Credit Receivable [Member] | ||
Prepaid Expenses And Other Current Assets [Line Items] | ||
Research and development tax credits receivable | $ 0.1 |
Accrued Expenses and Other Cu_3
Accrued Expenses and Other Current Liabilities - Summary of Accrued Expenses and Other Current Liabilities (Detail) - USD ($) $ in Thousands | Jun. 30, 2021 | Dec. 31, 2020 |
Payables And Accruals [Abstract] | ||
Accrued contracted research and development costs | $ 1,214 | $ 2,627 |
Accrued compensation | 1,528 | 1,920 |
Accrued general and administrative costs | 647 | 853 |
Lease liability | 102 | 179 |
Total accrued expenses and other current liabilities | $ 3,491 | $ 5,579 |
Short-term Investments - Summar
Short-term Investments - Summary of Major Security and Type of Investments (Detail) - USD ($) $ in Thousands | Jun. 30, 2021 | Dec. 31, 2020 |
Schedule Of Available For Sale Securities [Line Items] | ||
Amortized Cost | $ 140,020 | $ 59,307 |
Gross Unrealized Gains | 5 | 4 |
Gross Unrealized Losses | (7) | (3) |
Fair Value | 140,018 | 59,308 |
U.S. Government Securities [Member] | ||
Schedule Of Available For Sale Securities [Line Items] | ||
Amortized Cost | 13,151 | 13,296 |
Gross Unrealized Gains | 3 | 1 |
Fair Value | 13,154 | 13,297 |
Asset Backed Securities [Member] | ||
Schedule Of Available For Sale Securities [Line Items] | ||
Amortized Cost | 14,013 | 2,559 |
Gross Unrealized Losses | (2) | |
Fair Value | 14,011 | 2,559 |
Corporate Securities [Member] | ||
Schedule Of Available For Sale Securities [Line Items] | ||
Amortized Cost | 53,220 | 19,479 |
Gross Unrealized Gains | 2 | 3 |
Gross Unrealized Losses | (5) | (3) |
Fair Value | 53,217 | 19,479 |
Commercial Paper [Member] | ||
Schedule Of Available For Sale Securities [Line Items] | ||
Amortized Cost | 59,636 | 23,973 |
Fair Value | $ 59,636 | $ 23,973 |
Short-term Investments - Additi
Short-term Investments - Additional Information (Detail) - USD ($) | 6 Months Ended | |
Jun. 30, 2021 | Jun. 30, 2020 | |
Investments Debt And Equity Securities [Abstract] | ||
Realized gains or losses on investments | $ 0 | $ 0 |
Debt Facility - Additional Info
Debt Facility - Additional Information (Detail) - Loan and Security Agreement [Member] - Silicon Valley Bank [Member] - USD ($) $ in Millions | Mar. 30, 2021 | Jan. 31, 2020 | Apr. 28, 2017 | Jun. 30, 2021 |
Debt Instrument [Line Items] | ||||
Loan agreement amendment date | Oct. 31, 2017 | |||
Loan agreement amendment date one | Dec. 4, 2018 | |||
Loan agreement amendment date two | Jan. 31, 2020 | |||
Loan agreement amendment date three | Mar. 30, 2021 | |||
Term Loan [Member] | ||||
Debt Instrument [Line Items] | ||||
Debt instrument payment description | The Fourth Amendment provided that if by June 30, 2021, the Company did not have an ongoing phase 3 clinical trial evaluating its molgramostim product for the treatment of aPAP in which the first patient has been identified and dosed (the “Trial Requirement”), the interest-only period would end and principal plus interest would be due in equal monthly installments over 24 months. | |||
Frequency of principal plus interest repayment period | equal monthly installments | |||
Debt instrument principal and interest payment period | 24 months | |||
Debt instrument, date of first required payment | Jul. 1, 2021 | |||
Debt instrument, date of first required payment upon meeting trial requirement | Jul. 1, 2022 | |||
Prepayment fee percentage | 7.75% | |||
Gross cash proceeds from sale of equity securities | $ 25 | |||
Interest rate, basis spread | 3.00% | |||
Term Loan [Member] | End of Term Charge [Member] | ||||
Debt Instrument [Line Items] | ||||
Prepayment fee percentage | 6.20% | 6.00% | ||
Term Loan [Member] | Prepayment Fee 13-24 Months [Member] | ||||
Debt Instrument [Line Items] | ||||
Prepayment fee percentage | 2.00% | |||
Term Loan [Member] | Prepayment Fee Thereafter [Member] | ||||
Debt Instrument [Line Items] | ||||
Prepayment fee percentage | 1.00% |
Debt Facility - Carrying Value
Debt Facility - Carrying Value and Future Minimum Payments (Detail) - USD ($) $ in Thousands | Jun. 30, 2021 | Dec. 31, 2020 |
Debt Disclosure [Abstract] | ||
2022 | $ 8,333 | |
2023 | 18,167 | $ 8,333 |
2023 | 18,167 | |
Total future minimum payments | 26,500 | 26,500 |
Unamortized end of term charge | (920) | (1,134) |
Debt issuance costs | (113) | (149) |
Debt discount related to warrants | (86) | (113) |
Total debt | 25,381 | 25,104 |
Debt facility | $ 25,381 | $ 25,104 |
License Agreement - Additional
License Agreement - Additional Information (Details) - USD ($) shares in Millions | 6 Months Ended | 12 Months Ended | |
Jun. 30, 2020 | Dec. 31, 2020 | Jun. 30, 2021 | |
Organization Consolidation And Presentation Of Financial Statements [Abstract] | |||
Upfront cash payment | $ 3,300,000 | ||
Upfront payment common stock shares issued | 1 | ||
Upfront payment value of common stock issued | $ 2,100,000 | ||
Research and development expense | $ 5,400,000 | ||
License agreement, contingent consideration liability | $ 0 |
Fair Value Measurements - Addit
Fair Value Measurements - Additional Information (Detail) - USD ($) $ in Millions | 6 Months Ended | |
Jun. 30, 2021 | Jun. 30, 2020 | |
Fair Value Disclosures [Abstract] | ||
Increase decrease in carrying value of IPR&D due to foreign currency translation | $ 0.4 | $ 0.1 |
Fair Value Measurements - Summa
Fair Value Measurements - Summary of Fair Value of Financial Instruments (Detail) - USD ($) $ in Thousands | Jun. 30, 2021 | Dec. 31, 2020 |
U.S. Treasury Money Market Funds [Member] | ||
Cash equivalents: | ||
Cash equivalents | $ 38,706 | $ 21,872 |
U.S. Government Securities [Member] | ||
Short-term investments: | ||
Short-term investments | 13,154 | 13,297 |
Asset Backed Securities [Member] | ||
Short-term investments: | ||
Short-term investments | 14,011 | 2,559 |
Corporate Securities [Member] | ||
Short-term investments: | ||
Short-term investments | 53,217 | 19,479 |
Commercial Paper [Member] | ||
Short-term investments: | ||
Short-term investments | 59,636 | 23,973 |
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 | 38,706 | 21,872 |
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 | 13,154 | 13,297 |
Fair Value, Measurements, Recurring [Member] | Significant Other Observable Inputs (Level 2) [Member] | Asset Backed Securities [Member] | ||
Short-term investments: | ||
Short-term investments | 14,011 | 2,559 |
Fair Value, Measurements, Recurring [Member] | Significant Other Observable Inputs (Level 2) [Member] | Corporate Securities [Member] | ||
Short-term investments: | ||
Short-term investments | 53,217 | 19,479 |
Fair Value, Measurements, Recurring [Member] | Significant Other Observable Inputs (Level 2) [Member] | Commercial Paper [Member] | ||
Short-term investments: | ||
Short-term investments | $ 59,636 | $ 23,973 |
Derivative Financial Instrume_2
Derivative Financial Instruments - Additional Information (Detail) - Forward Exchange Contracts [Member] - USD ($) | Jun. 30, 2021 | Jun. 30, 2020 |
Derivative [Line Items] | ||
Unsettled forward exchange contracts to purchase foreign currency | $ 0 | $ 3,000,000 |
Derivative liabilities, fair value | $ 3,000,000 |
Shareholders' Equity - Addition
Shareholders' Equity - Additional Information (Detail) - USD ($) | Jul. 06, 2021 | Jul. 02, 2021 | Mar. 15, 2021 | Jun. 28, 2018 | Jun. 30, 2021 | Mar. 31, 2021 | Jun. 30, 2021 | Jun. 30, 2020 | Dec. 31, 2020 | Apr. 28, 2017 | ||
Class Of Warrant Or Right [Line Items] | ||||||||||||
Common stock, par value | $ 0.001 | $ 0.001 | $ 0.001 | |||||||||
Net proceeds after deducting underwriting discounts commissions and offering expenses | $ 122,148,000 | |||||||||||
Aggregate number of shares of common stock | 47,765,615 | 47,765,615 | 45,133,986 | |||||||||
Issuance of common stock and pre-funded warrants in public offering, net of offering costs | $ 321,000 | $ 121,827,000 | [1] | |||||||||
H.C. Wainwright & Co., LLC [Member] | ||||||||||||
Class Of Warrant Or Right [Line Items] | ||||||||||||
Common stock, shares sold | 0 | 942,825 | ||||||||||
Common stock, par value | $ 0.001 | |||||||||||
Net proceeds from sale of shares | $ 2,300,000 | |||||||||||
H.C. Wainwright & Co., LLC [Member] | Subsequent Event [Member] | ||||||||||||
Class Of Warrant Or Right [Line Items] | ||||||||||||
Termination of agreement | July 12, 2021 | |||||||||||
H.C. Wainwright & Co., LLC [Member] | Maximum [Member] | ||||||||||||
Class Of Warrant Or Right [Line Items] | ||||||||||||
Amount available to sell under equity program | $ 60,000 | |||||||||||
Evercore Group L.L.C., [Member] | Subsequent Event [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 sales agreement, effective date | Jul. 16, 2021 | |||||||||||
Evercore Group L.L.C., [Member] | Maximum [Member] | Subsequent Event [Member] | ||||||||||||
Class Of Warrant Or Right [Line Items] | ||||||||||||
Amount available to sell under equity program | $ 60,000,000 | |||||||||||
Warrant Repurchase [Member] | ||||||||||||
Class Of Warrant Or Right [Line Items] | ||||||||||||
Common stock, par value | $ 0.15 | $ 0.15 | ||||||||||
Warrants and rights outstanding | $ 3,900,000 | $ 3,900,000 | ||||||||||
Warrant Repurchase [Member] | Milestone Warrants [Member] | ||||||||||||
Class Of Warrant Or Right [Line Items] | ||||||||||||
Warrant to purchase of common stock | 26,061,769 | |||||||||||
Aggregate number of shares of common stock | 3,474,902 | 3,474,902 | ||||||||||
Common Stock [Member] | ||||||||||||
Class Of Warrant Or Right [Line Items] | ||||||||||||
Issuance of common stock and pre-funded warrants in public offering, net of offering costs | [1] | $ 57,000 | ||||||||||
Common Stock [Member] | H.C. Wainwright & Co., LLC [Member] | ||||||||||||
Class Of Warrant Or Right [Line Items] | ||||||||||||
Issuance of common stock and pre-funded warrants in public offering, net of offering costs | $ 2,300,000 | |||||||||||
Public Offering of Common Stock [Member] | ||||||||||||
Class Of Warrant Or Right [Line Items] | ||||||||||||
Common stock, shares sold | 57,479,978 | |||||||||||
Common stock, par value | $ 0.001 | |||||||||||
Common stock, sale of stock, price per share | $ 1.45 | |||||||||||
Common stock, shares issued to underwriters | 11,694,150 | |||||||||||
Common stock, pre-funded warrants to purchase | 32,175,172 | |||||||||||
Common Stock pre funded warrants exercise price | $ 0.001 | |||||||||||
Common Stock pre funded warrants per warrant | $ 1.449 | |||||||||||
Net proceeds after deducting underwriting discounts commissions and offering expenses | $ 122,100,000 | |||||||||||
[1] | As discussed in Note 10. Stockholders’ Equity , |
Shareholders' Equity - Summary
Shareholders' Equity - Summary of Net Proceeds after Deducting Underwriting Discounts Commissions and Offering Expenses (Detail) $ in Thousands | 6 Months Ended |
Jun. 30, 2021USD ($) | |
Class Of Warrant Or Right [Line Items] | |
Total common stock and pre-funded warrants | $ 129,968 |
Offering expenses | (7,820) |
Net proceeds | 122,148 |
Common Stock [Member] | |
Class Of Warrant Or Right [Line Items] | |
Total common stock and pre-funded warrants | 83,346 |
Pre-Funded Warrants [Member] | |
Class Of Warrant Or Right [Line Items] | |
Total common stock and pre-funded warrants | $ 46,622 |
Shareholders' Equity - Company'
Shareholders' Equity - Company's Shares of Common Stock Reserved for Issuance (Detail) - shares | Jun. 30, 2021 | Dec. 31, 2020 |
Class Of Warrant Or Right [Line Items] | ||
Total shares reserved | 47,765,615 | 45,133,986 |
Warrants Acquired in April 2017 Merger [Member] | ||
Class Of Warrant Or Right [Line Items] | ||
Total shares reserved | 403,927 | |
Warrants Converted In Connection With April 2017 Merger [Member] | ||
Class Of Warrant Or Right [Line Items] | ||
Total shares reserved | 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 | 3,474,902 | 31,274,121 |
2021 Pre-funded Warrants [Member] | ||
Class Of Warrant Or Right [Line Items] | ||
Total shares reserved | 32,175,172 | |
Stock Options Outstanding [Member] | ||
Class Of Warrant Or Right [Line Items] | ||
Total shares reserved | 5,125,189 | 6,240,342 |
Issued and nonvested RSUs [Member] | ||
Class Of Warrant Or Right [Line Items] | ||
Total shares reserved | 357,022 | 509,397 |
Shareholders' Equity - Summar_2
Shareholders' Equity - Summary of Outstanding Warrants for Company's Common Stock (Detail) | 6 Months Ended |
Jun. 30, 2021$ / sharesshares | |
Class Of Warrant Or Right [Line Items] | |
Shares Underlying Outstanding Warrants | 42,283,404 |
Exercise Price One [Member] | |
Class Of Warrant Or Right [Line Items] | |
Expiration Date | 2024-10 |
Shares Underlying Outstanding Warrants | 775,000 |
Exercise Price | $ / shares | $ 0.01 |
Exercise Price Two [Member] | |
Class Of Warrant Or Right [Line Items] | |
Expiration Date | 2027-04 |
Shares Underlying Outstanding Warrants | 24,725 |
Exercise Price | $ / shares | $ 2.87 |
Exercise Price Three [Member] | |
Class Of Warrant Or Right [Line Items] | |
Expiration Date | 2027-06 |
Shares Underlying Outstanding Warrants | 41,736 |
Exercise Price | $ / shares | $ 2.87 |
Exercise Price Four [Member] | |
Class Of Warrant Or Right [Line Items] | |
Expiration Date | 2028-12 |
Shares Underlying Outstanding Warrants | 11,332 |
Exercise Price | $ / shares | $ 2.87 |
Exercise Price Five [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 Six [Member] | |
Class Of Warrant Or Right [Line Items] | |
Shares Underlying Outstanding Warrants | 3,474,902 |
Exercise Price | $ / shares | $ 1.48 |
Expiration Date | Earlier of December 2021 or 30 days after clinical milestone |
Exercise Price Seven [Member] | |
Class Of Warrant Or Right [Line Items] | |
Shares Underlying Outstanding Warrants | 32,175,172 |
Exercise Price | $ / shares | $ 0.001 |
Expiration Date | None |
Shareholders' Equity - Componen
Shareholders' Equity - Components of Accumulated Other Comprehensive Income (Loss) (Detail) - USD ($) $ in Thousands | 6 Months Ended | 12 Months Ended |
Jun. 30, 2021 | Dec. 31, 2020 | |
Accumulated Other Comprehensive Income Loss [Line Items] | ||
Total Accumulated Other Comprehensive Income (Loss) | $ 942 | $ (17) |
Change | (350) | 959 |
Total Accumulated Other Comprehensive Income (Loss) | 592 | 942 |
Foreign Exchange Translation Adjustment [Member] | ||
Accumulated Other Comprehensive Income Loss [Line Items] | ||
Total Accumulated Other Comprehensive Income (Loss) | 941 | (65) |
Change | (348) | 1,006 |
Total Accumulated Other Comprehensive Income (Loss) | 593 | 941 |
Unrealized Gain (Loss) on ST Investments [Member] | ||
Accumulated Other Comprehensive Income Loss [Line Items] | ||
Total Accumulated Other Comprehensive Income (Loss) | 1 | 48 |
Change | (2) | (47) |
Total Accumulated Other Comprehensive Income (Loss) | $ (1) | $ 1 |
Commitments - Additional Inform
Commitments - Additional Information (Detail) - USD ($) | Mar. 05, 2021 | Jun. 30, 2021 |
Commitments And Contingencies [Line Items] | ||
Decrease in milestone payment related to the removal of Nebulizer System | $ 5,000,000 | |
Contingent milestones commitments recognized | 0 | |
Research and development expense for termination | $ 800,000 | |
Estimated service fees and pass-through expenses | $ 31,000,000 | |
Active Pharmaceutical Ingredients [Member] | ||
Commitments And Contingencies [Line Items] | ||
Agreement description | Under a manufacture and supply agreement with the active pharmaceutical ingredients (“API”) manufacturer for molgramostim, 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 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. | |
Nebulizer [Member] | ||
Commitments And Contingencies [Line Items] | ||
Royalty percent on net sale | 3.50% |
Commitments - Schedule of Manuf
Commitments - Schedule of Manufacturing Commitments and Contingencies (Detail) $ in Thousands | 6 Months Ended |
Jun. 30, 2021USD ($) | |
Commitments And Contingencies [Line Items] | |
Total manufacturing and other commitments | $ 2,907 |
Active Pharmaceutical Ingredients [Member] | |
Commitments And Contingencies [Line Items] | |
Achievement of certain milestones related to validation of API and regulatory approval of molgramostim | 2,300 |
Molgramostim Nebulizer Manufacturer [Member] | |
Commitments And Contingencies [Line Items] | |
Achievement of various development activities and regulatory approval of nebulizer utilized to administer molgramostim | $ 607 |
Stock-Based Compensation - Addi
Stock-Based Compensation - Additional Information (Detail) | 6 Months Ended |
Jun. 30, 2021shares | |
2008 Stock Option Plan [Member] | Stock Options [Member] | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |
Issuance of stock based awards | 0 |
2015 Omnibus Incentive Option Plan [Member] | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |
Common stock available for grant | 2,253,456 |
2015 Omnibus Incentive Option Plan [Member] | Stock Options [Member] | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |
Dividend yield | 0.00% |
2008 Plan and 2015 Plan [Member] | Stock Options [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 Plan and 2015 Plan [Member] | RSUs [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 |
2021 Inducement Equity Incentive Plan [Member] | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |
Common stock available for grant | 425,000 |
2021 Inducement Equity Incentive Plan [Member] | Stock Options [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 |
2021 Inducement Equity Incentive Plan [Member] | RSUs [Member] | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |
Vesting period | 2 years |
Stock-Based Compensation - Summ
Stock-Based Compensation - Summary of Stock-based Awards Activity Under the 2008 Plan and 2015 Plan (Detail) - shares | 6 Months Ended | |
Jun. 30, 2021 | Jun. 30, 2020 | |
Disclosure Of Compensation Related Costs Sharebased Payments [Abstract] | ||
Stock Options, Outstanding at beginning balance | 6,240,343 | 4,541,432 |
Stock Options, Granted | 245,000 | 32,000 |
Stock Options, Exercised | (705,908) | (64,546) |
Stock Options, Forfeited | (654,246) | (105,094) |
Stock Options, Outstanding at ending balance | 5,125,189 | 4,403,792 |
RSUs, Outstanding at beginning balance | 509,397 | 315,625 |
RSUs, Granted | 100,000 | |
RSUs, Exercised | (209,250) | (25,500) |
RSUs, Forfeited | (43,125) | |
RSUs, Outstanding at ending balance | 357,022 | 290,125 |
Total, Outstanding at beginning balance | 6,749,740 | 4,857,057 |
Total, Granted | 345,000 | 32,000 |
Total, Exercised | (915,158) | (90,046) |
Total, Forfeited | (697,371) | (105,094) |
Total, Outstanding at ending balance | 5,482,211 | 4,693,917 |
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 | 6 Months Ended | ||
Jun. 30, 2021 | Jun. 30, 2020 | Jun. 30, 2021 | Jun. 30, 2020 | |
Employee Service Share Based Compensation Allocation Of Recognized Period Costs [Line Items] | ||||
Total stock-based compensation | $ 771 | $ 1,175 | $ 1,717 | $ 2,369 |
Research and Development [Member] | ||||
Employee Service Share Based Compensation Allocation Of Recognized Period Costs [Line Items] | ||||
Total stock-based compensation | 291 | 358 | 755 | 951 |
General and Administrative [Member] | ||||
Employee Service Share Based Compensation Allocation Of Recognized Period Costs [Line Items] | ||||
Total stock-based compensation | $ 480 | $ 817 | $ 962 | $ 1,418 |
Net Loss Per Share - Schedule o
Net Loss Per Share - Schedule of Anti-dilutive Equity Instruments Excluded from Calculation of Diluted Net Loss Per Share (Detail) - shares | 6 Months Ended | |
Jun. 30, 2021 | Jun. 30, 2020 | |
Earnings Per Share Basic [Line Items] | ||
Anti-dilutive securities excluded from calculation of diluted net loss per share | 9,034,906 | 37,825,715 |
Awards under Equity Incentive Plan [Member] | ||
Earnings Per Share Basic [Line Items] | ||
Anti-dilutive securities excluded from calculation of diluted net loss per share | 5,125,189 | 4,403,792 |
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 | 357,022 | 290,125 |
Warrants to Purchase Common Stock [Member] | ||
Earnings Per Share Basic [Line Items] | ||
Anti-dilutive securities excluded from calculation of diluted net loss per share | 3,552,695 | 33,131,798 |
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 | 6 Months Ended | ||||
Jun. 30, 2021 | Mar. 31, 2021 | Jun. 30, 2020 | Mar. 31, 2020 | Jun. 30, 2021 | Jun. 30, 2020 | |
Earnings Per Share [Abstract] | ||||||
Net loss | $ (10,941) | $ (10,217) | $ (9,389) | $ (15,421) | $ (21,158) | $ (24,811) |
Net loss attributable to common stockholders | (10,941) | (9,389) | (21,158) | (24,811) | ||
Undistributed earnings and net loss attributable to common stockholders, basic and diluted | $ (10,941) | $ (9,389) | $ (21,158) | $ (24,811) | ||
Weighted average common shares outstanding, basic and diluted | 152,460,531 | 58,858,216 | 114,934,938 | 58,111,225 | ||
Basic and diluted EPS | $ (0.07) | $ (0.16) | $ (0.18) | $ (0.43) |
Subsequent Events - Additional
Subsequent Events - Additional Information (Detail) - Subsequent Event [Member] - USD ($) $ in Millions | Aug. 05, 2021 | Jul. 06, 2021 | Jul. 02, 2021 |
Subsequent Event [Line Items] | |||
Sublease expiry month and year | 2021-07 | ||
Lease agreement date | Jun. 3, 2021 | ||
Lease commencement date | Aug. 1, 2021 | ||
Lease expiration date | Dec. 31, 2022 | ||
Operating lease liability | $ 0.1 | ||
Operating lease right of use asset | $ 0.1 | ||
H.C. Wainwright & Co., LLC [Member] | |||
Subsequent Event [Line Items] | |||
Termination of agreement | July 12, 2021 | ||
Evercore [Member] | |||
Subsequent Event [Line Items] | |||
Common stock sales agreement, effective date | Jul. 16, 2021 |