Document and Entity Information
Document and Entity Information - shares | 9 Months Ended | |
Sep. 30, 2022 | Nov. 10, 2022 | |
Cover [Abstract] | ||
Document Type | 10-Q | |
Amendment Flag | false | |
Document Period End Date | Sep. 30, 2022 | |
Document Fiscal Year Focus | 2022 | |
Document Fiscal Period Focus | Q3 | |
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 | 114,044,001 | |
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 $0.001 per share | |
Trading Symbol | SVRA | |
Security Exchange Name | NASDAQ |
Condensed Consolidated Balance
Condensed Consolidated Balance Sheets (Unaudited) - USD ($) $ in Thousands | Sep. 30, 2022 | Dec. 31, 2021 |
Current assets: | ||
Cash and cash equivalents | $ 119,841 | $ 34,012 |
Short-term investments | 14,236 | 127,159 |
Prepaid expenses and other current assets | 2,992 | 3,829 |
Total current assets | 137,069 | 165,000 |
Property and equipment, net | 59 | 73 |
In-process R&D | 9,754 | 11,274 |
Other non-current assets | 876 | 251 |
Total assets | 147,758 | 176,598 |
Current liabilities: | ||
Accounts payable | 893 | 1,443 |
Accrued expenses and other current liabilities | 4,270 | 4,884 |
Current portion of long-term debt | 8,333 | |
Total current liabilities | 5,163 | 14,660 |
Long-term liabilities: | ||
Long-term debt | 26,010 | 17,323 |
Other long-term liabilities | 71 | 117 |
Total liabilities | 31,244 | 32,100 |
Commitments and Contingencies (Note 9) | ||
Stockholders’ equity: | ||
Common stock, $0.001 par value, 300,000,000 authorized as of September 30, 2022 and December 31, 2021; 114,042,642 and 114,036,892 shares issued and outstanding as of September 30, 2022 and December 31, 2021, respectively | 116 | 116 |
Additional paid-in capital | 446,376 | 444,898 |
Accumulated other comprehensive (loss) income | (1,607) | 5 |
Accumulated deficit | (328,371) | (300,521) |
Total stockholders’ equity | 116,514 | 144,498 |
Total liabilities and stockholders’ equity | $ 147,758 | $ 176,598 |
Condensed Consolidated Balanc_2
Condensed Consolidated Balance Sheets (Unaudited) (Parenthetical) - $ / shares | Sep. 30, 2022 | Dec. 31, 2021 |
Statement of Financial Position [Abstract] | ||
Common stock, par value | $ 0.001 | $ 0.001 |
Common stock, shares authorized | 300,000,000,000 | 300,000,000,000 |
Common stock, shares issued | 114,042,642 | 114,036,892 |
Common stock, shares outstanding | 114,042,642 | 114,036,892 |
Condensed Consolidated Statemen
Condensed Consolidated Statements of Operations and Comprehensive Loss (Unaudited) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2022 | Sep. 30, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | |
Operating expenses: | ||||
Research and development | $ 8,151 | $ 6,532 | $ 20,253 | $ 21,373 |
General and administrative | 2,376 | 3,400 | 7,687 | 9,331 |
Depreciation and amortization | 8 | 40 | 24 | 134 |
Total operating expenses | 10,535 | 9,972 | 27,964 | 30,838 |
Loss from operations | (10,535) | (9,972) | (27,964) | (30,838) |
Other income (expense) | ||||
Interest income (expense) | 152 | (566) | (702) | (1,717) |
Foreign currency exchange (loss) gain | (8) | (8) | 21 | (22) |
Tax credit income | 5 | 795 | 873 | |
Total other income (expense), net | 149 | (574) | 114 | (866) |
Net loss | $ (10,386) | $ (10,546) | $ (27,850) | $ (31,704) |
Net loss per share: | ||||
Basic | $ (0.07) | $ (0.07) | $ (0.18) | $ (0.25) |
Diluted | $ (0.07) | $ (0.07) | $ (0.18) | $ (0.25) |
Weighted-average common shares outstanding: | ||||
Basic | 152,773,015 | 152,587,848 | 152,771,302 | 127,623,824 |
Diluted | 152,773,015 | 152,587,848 | 152,771,302 | 127,623,824 |
Other comprehensive loss: | ||||
Loss on foreign currency translation | $ (668) | $ (297) | $ (1,621) | $ (645) |
Unrealized gain (loss) on short-term investments | 77 | (10) | 9 | (12) |
Total comprehensive loss | $ (10,977) | $ (10,853) | $ (29,462) | $ (32,361) |
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, 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 | 2,546 | $ 2 | 2,544 | |||
Net issuance of common stock upon exercise of stock warrants, 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) | ||||
Ending balances 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 | |||||
Foreign exchange translation adjustment | (645) | |||||
Unrealized gain (loss) on short-term investments | (12) | |||||
Net loss | (31,704) | |||||
Ending balances at Sep. 30, 2021 | 155,229 | $ 115 | 444,040 | (289,211) | 285 | |
Ending balance, shares at Sep. 30, 2021 | 113,866,997 | |||||
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) | ||||
Ending balances at Jun. 30, 2021 | 165,382 | $ 114 | 443,341 | (278,665) | 592 | |
Ending balance, shares at Jun. 30, 2021 | 113,847,532 | |||||
Issuance of common stock for settlement of RSUs, shares | 3,688 | |||||
Issuance of common stock upon exercise of stock options | 10 | $ 1 | 9 | |||
Issuance of common stock upon exercise of stock options, shares | 15,777 | |||||
Stock-based compensation | 690 | 690 | ||||
Foreign exchange translation adjustment | (297) | (297) | ||||
Unrealized gain (loss) on short-term investments | (10) | (10) | ||||
Net loss | (10,546) | (10,546) | ||||
Ending balances at Sep. 30, 2021 | 155,229 | $ 115 | 444,040 | (289,211) | 285 | |
Ending balance, shares at Sep. 30, 2021 | 113,866,997 | |||||
Beginning balances at Dec. 31, 2021 | $ 144,498 | $ 116 | 444,898 | (300,521) | 5 | |
Beginning balance, shares at Dec. 31, 2021 | 114,036,892 | 114,036,892 | ||||
Repurchase of shares for minimum tax withholdings | $ (1) | (1) | ||||
Repurchase of shares for minimum tax withholdings, shares | (720) | |||||
Issuance of common stock for settlement of RSUs, shares | 3,688 | |||||
Stock-based compensation | 574 | 574 | ||||
Foreign exchange translation adjustment | (208) | (208) | ||||
Unrealized gain (loss) on short-term investments | (88) | (88) | ||||
Net loss | (8,300) | (8,300) | ||||
Ending balances at Mar. 31, 2022 | 136,475 | $ 116 | 445,471 | (308,821) | (291) | |
Ending balance, shares at Mar. 31, 2022 | 114,039,860 | |||||
Beginning balances at Dec. 31, 2021 | $ 144,498 | $ 116 | 444,898 | (300,521) | 5 | |
Beginning balance, shares at Dec. 31, 2021 | 114,036,892 | 114,036,892 | ||||
Issuance of common stock for settlement of RSUs, shares | 7,313 | |||||
Issuance of common stock upon exercise of stock options, shares | 0 | |||||
Foreign exchange translation adjustment | $ (1,621) | |||||
Unrealized gain (loss) on short-term investments | 9 | |||||
Net loss | (27,850) | |||||
Ending balances at Sep. 30, 2022 | $ 116,514 | $ 116 | 446,376 | (328,371) | (1,607) | |
Ending balance, shares at Sep. 30, 2022 | 114,042,642 | 114,042,642 | ||||
Beginning balances at Mar. 31, 2022 | $ 136,475 | $ 116 | 445,471 | (308,821) | (291) | |
Beginning balance, shares at Mar. 31, 2022 | 114,039,860 | |||||
Repurchase of shares for minimum tax withholdings, shares | (401) | |||||
Issuance of common stock for settlement of RSUs, shares | 1,812 | |||||
Stock-based compensation | 456 | 456 | ||||
Foreign exchange translation adjustment | (745) | (745) | ||||
Unrealized gain (loss) on short-term investments | 20 | 20 | ||||
Net loss | (9,164) | (9,164) | ||||
Ending balances at Jun. 30, 2022 | 127,042 | $ 116 | 445,927 | (317,985) | (1,016) | |
Ending balance, shares at Jun. 30, 2022 | 114,041,271 | |||||
Repurchase of shares for minimum tax withholdings | (1) | (1) | ||||
Repurchase of shares for minimum tax withholdings, shares | (442) | |||||
Issuance of common stock for settlement of RSUs, shares | 1,813 | |||||
Stock-based compensation | 450 | 450 | ||||
Foreign exchange translation adjustment | (668) | (668) | ||||
Unrealized gain (loss) on short-term investments | 77 | 77 | ||||
Net loss | (10,386) | (10,386) | ||||
Ending balances at Sep. 30, 2022 | $ 116,514 | $ 116 | $ 446,376 | $ (328,371) | $ (1,607) | |
Ending balance, shares at Sep. 30, 2022 | 114,042,642 | 114,042,642 | ||||
[1] As discussed in Note 8. Stockholders’ Equity , the Company sold (i) an aggregate of 57,479,978 shares of the Company’s common stock, par value $ 0.001 per share and (ii) pre-funded warrants to purchase an aggregate of 32,175,172 shares of the Company's common stock at an exercise price, equal to the par value, of $ 0.001 per share. |
Condensed Consolidated Statem_3
Condensed Consolidated Statements of Changes in Stockholders' Equity (Unaudited) (Parenthetical) - $ / shares | Mar. 15, 2021 | Mar. 05, 2021 | Sep. 30, 2022 | Dec. 31, 2021 |
Common stock, par value | $ 0.001 | $ 0.001 | ||
Public Offering [Member] | ||||
Common stock, shares sold | 57,479,978 | |||
Common stock, par value | $ 0.001 | |||
Common stock, pre-funded warrants to purchase | 32,175,172 | 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 | 9 Months Ended | ||
Sep. 30, 2022 | Sep. 30, 2021 | ||
Cash flows from operating activities: | |||
Net loss | $ (27,850) | $ (31,704) | |
Adjustments to reconcile net loss to net cash used in operating activities: | |||
Depreciation and amortization | 24 | 134 | |
Amortization of right-of-use assets | 101 | 96 | |
Foreign currency (gain) loss | (21) | 22 | |
Amortization of debt issuance costs | 266 | 413 | |
Amortization on premium to short-term investments | 432 | 1,169 | |
Stock-based compensation | 1,480 | 2,407 | |
Changes in operating assets and liabilities: | |||
Prepaid expenses and other current assets | 1,257 | (768) | |
Non-current assets | (828) | (884) | |
Accounts payable and accrued expenses and other current liabilities | (764) | (1,485) | |
Long-term liabilities | (118) | ||
Net cash used in operating activities | (25,903) | (30,718) | |
Cash flows from investing activities: | |||
Purchase of property and equipment | (9) | (17) | |
Purchase of available-for-sale securities, net | (16,004) | (138,541) | |
Maturities of available-for-sale securities | 116,593 | 67,870 | |
Sale of available-for-sale securities, net | 11,276 | 2,500 | |
Net cash provided by (used in) investing activities | 111,856 | (68,188) | |
Cash flows from financing activities: | |||
Repurchase of outstanding pre-funded warrants | (3,909) | ||
Repayment of long-term debt | (26,350) | ||
Proceeds from long-term debt, net | [1] | 26,438 | |
Issuance of common stock and pre-funded warrants in public offering, net of offering costs | 122,148 | ||
Proceeds from exercise of stock options | 15 | ||
Issuance of common stock upon exercise of warrants, net | 2,546 | ||
Repurchase of shares for minimum tax withholdings | (2) | ||
Net cash provided by financing activities | 86 | 120,800 | |
Effect of exchange rate changes on cash and cash equivalents | (210) | (75) | |
Increase in cash and cash equivalents | 85,829 | 21,819 | |
Cash and cash equivalents beginning of period | 34,012 | 22,880 | |
Cash and cash equivalents end of period | 119,841 | 44,699 | |
Supplemental disclosure of cash flow information: | |||
Cash paid for interest | $ 1,186 | $ 1,469 | |
[1] As discussed in Note 6. Long-term Debt , the Amended Loan Agreement (as defined herein) was accounted for as a modification. The Company used the proceeds from the Amended Loan Agreement to repay the outstanding amounts under the Loan Agreement from Silicon Valley Bank. |
Organization and Nature of Oper
Organization and Nature of Operations | 9 Months Ended |
Sep. 30, 2022 | |
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 biopharmaceutical company focused on rare respiratory diseases. The Company’s lead program, molgramostim nebulizer solution (“molgramostim”), a novel inhaled biologic, is a granulocyte-macrophage colony-stimulating factor in Phase 3 development for autoimmune pulmonary alveolar proteinosis (“aPAP”). The Company and its wholly-owned subsidiaries operate in one segment with its principal office in Austin, Texas. Since inception, Savara has devoted 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. Previously, the Company's pipeline included vancomycin hydrochloride inhalation powder (“vancomycin”) for persistent methicillin-resistant Staphylococcus aureus lung infection in people living with cystic fibrosis (“CF”) and inhaled ciprofloxacin (formerly referred to as Apulmiq) for non-CF bronchiectasis. |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 9 Months Ended |
Sep. 30, 2022 | |
Accounting Policies [Abstract] | |
Summary of Significant Accounting Policies | 2. Summary of Significant Accounting Policies Basis of Presentation The unaudited 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, 2022 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, 2021 . The Company’s significant accounting policies are described in Note 2 to the audited consolidated financial statements. There have been no changes to the Company's significant accounting policies since the date of those financial statements. 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 (loss) income in the condensed consolidated balance sheet. All intercompany transactions and accounts have been eliminated in consolidation. The condensed consolidated balance sheet at December 31, 2021 has been derived from the Company's audited consolidated financial statements at that date but does not include all of the information and notes required by U.S. GAAP for complete financial statements. Liquidity As of September 30, 2022, the Company had an accumulated deficit of approximately $ 328.4 million. The Company used cash in operating activities of approximately $ 25.9 million during the nine months ended September 30, 2022. 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 for the treatment of aPAP 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. The Company intends to cover its future operating expenses through cash and cash equivalents on hand, short-term investments and, potentially, through a combination of equity offerings, debt financings, government or other third-party funding, and other collaborations and strategic alliances with partner companies. The Company cannot be sure that additional financing will be available when needed or that, if available, financing will be obtained on terms favorable to the Company or its stockholders. The Company’s cash and cash equivalents of $ 119.8 million and short-term investments of $ 14.2 million as of September 30, 2022 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, but are not limited to, those related to the accrual of research and development expenses and general and administrative costs, certain financial instruments recorded at fair value, the valuation of stock-based compensation, and the valuation allowance for deferred tax assets. The Company bases its estimates on historical experience, changes in circumstance and facts, 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. 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. The Company's chief operating decision maker is the Chief Executive Officer. We have one operating segment, specialty pharmaceuticals within the respiratory system. Recent Accounting Pronouncements There are no recent accounting pronouncements issued by the FASB, the AICPA, or the SEC that are believed by the Company's 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 | 9 Months Ended |
Sep. 30, 2022 | |
Prepaid Expense and Other Assets, Current [Abstract] | |
Prepaid Expenses and Other Current Assets | 3. Prepaid Expenses and Other Current Assets Prepaid expenses and other current assets consisted of the following (in thousands): September 30, 2022 December 31, 2021 Prepaid contracted research and development costs $ 1,789 $ 1,902 R&D tax credit receivable 725 838 VAT receivable 136 306 Prepaid insurance 240 427 Deposits and other 102 356 Total prepaid expenses and other current assets $ 2,992 $ 3,829 Prepaid Contracted Research and Development Costs As of September 30, 2022, Prepaid contracted research and development costs are primarily comprised of contractual prepayments associated with the Company's clinical trial for molgramostim for the treatment of aPAP. This includes prepaid amounts paid under agreements with contract research organizations (“CROs”), contract manufacturing organizations (“CMOs”), and other outside service providers that provide services in connection with the Company's research and development activities. R&D Tax Credit Receivable The Company has recorded a Danish tax credit earned by its subsidiary, Savara ApS, as of September 30, 2022 . 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, 2021, the Company generated a Danish tax credit of $ 0.7 million which is included in Prepaid expenses and other current assets and is expected to be received in the fourth quarter of 2022. During the nine months ended September 30, 2022, the Company generated a Danish tax credit of $ 0.7 million which is recorded in Other non-current assets in the condensed consolidated balance sheet and is expected to be received in the fourth quarter of 2023. |
Accrued Expenses and Other Curr
Accrued Expenses and Other Current Liabilities | 9 Months Ended |
Sep. 30, 2022 | |
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): September 30, 2022 December 31, 2021 Accrued contracted research and development costs $ 2,066 $ 1,623 Accrued compensation 1,615 2,526 Accrued general and administrative costs 507 600 Lease liability 82 135 Total accrued expenses and other current liabilities $ 4,270 $ 4,884 Accrued Contracted Research and Development Costs As of September 30, 2022, Accrued contracted research and development costs are primarily comprised of costs associated with molgramostim for the treatment of aPAP, including expenses resulting from obligations under agreements with CROs, CMOs, and other outside service providers that provide services in connection with the Company's research and development activities. Accrued Compensation As of September 30, 2022, Accrued compensation includes amounts to be paid to employees for salary, vacation and non-equity performance-based compensation. At the end of any period, the amounts accrued for such compensation may vary due to many factors including, but not limited to, timing of payments to employees and vacation usage |
Short-term Investments
Short-term Investments | 9 Months Ended |
Sep. 30, 2022 | |
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 September 30, 2022 Amortized Cost Gross Unrealized Gains Gross Unrealized Losses Fair Value Short-term investments U.S. government securities $ 8,078 $ — $ ( 40 ) $ 8,038 Commercial paper 6,198 — — 6,198 Total short-term investments $ 14,276 $ — $ ( 40 ) $ 14,236 As of December 31, 2021 Amortized Cost Gross Unrealized Gains Gross Unrealized Losses Fair Value Short-term investments U.S. government securities $ 12,205 $ — $ ( 15 ) $ 12,190 Asset backed securities 11,349 — ( 3 ) 11,346 Corporate securities 49,095 — ( 29 ) 49,066 Commercial paper 54,557 — — 54,557 Total short-term investments $ 127,206 $ — $ ( 47 ) $ 127,159 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 (loss) income in the condensed consolidated balance sheet. Classification as short-term or long-term is based upon whether the initial maturity of the debt securities is less than or greater than twelve months. There were no significant realized gains or losses related to investments for the three and nine months ended September 30, 2022 and 2021 . |
Long-term Debt
Long-term Debt | 9 Months Ended |
Sep. 30, 2022 | |
Debt Disclosure [Abstract] | |
Long-term Debt | 6. Long-term Debt On April 28, 2017, the Company and its subsidiary, Aravas Inc. (“Aravas”) 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 , the Third Amendment on January 31, 2020 , and the Fourth Amendment on March 30, 2021 (the “Loan Agreement”), pursuant to which Silicon Valley Bank provided a term loan to us in the principal amount of $ 25.0 million. On April 21, 2022 , the Company and Aravas, entered into an Amended and Restated Loan and Security Agreement (the “Amended Loan Agreement”), as co-borrowers, and Silicon Valley Bank, as lender (the “Lender”), which amended and restated the Loan Agreement in its entirety. The Amended Loan Agreement provides for a $ 26.5 million term loan facility. The Company used the proceeds from the Amended Loan Agreement to repay outstanding amounts under the Loan Agreement, including principal of $ 25.0 million, a prepayment fee of $ 0.1 million, and an end of term charge of $ 1.4 million. Pursuant to the Amended Loan Agreement, the loan has an interest-only monthly payment through April 21, 2026 (the “Interest-Only Period”) and thereafter equal monthly installments of principal plus interest over 12 months until April 21, 2027 (the “Maturity Date”). However, the Company may elect to extend the Interest-Only Period until the Maturity Date if it maintains cash and cash equivalents equal to at least 1.75 times the outstanding principal amount of the loan during the fifth year. If the Interest-Only Period is extended, all principal and unpaid interest is due and payable on the Maturity Date . The loan bears interest at a floating rate equal to the greater of (i) 3 % and (ii) the prime rate reported in The Wall Street Journal, minus a spread of 0.5 %. Savara is obligated to pay customary closing fees and a final payment of 2.75 % of the principal amount advanced under the facility. The Company may prepay the loan in whole or in part at any time, subject to a prepayment fee of 4.25 % if prepaid within the first anniversary of the closing date and 1.0 % if prepaid between the first and second anniversaries of the closing date. Following the second anniversary, there is no prepayment fee. Silicon Valley Bank was granted a perfected first priority lien in all of the Company's assets with a negative pledge on intellectual property. The Amended Loan Agreement contained customary affirmative and negative covenants, including among others, covenants that limit the Company's and its 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 Amended Loan Agreement contains an affirmative covenant providing that if the Company’s balance of cash and cash equivalents falls below $ 40.0 million, the Company is required to maintain cash and cash equivalents equal to at least (i) six months of operating expenses and (ii) 1.2 times the outstanding principal amount of the loan (or 1.75 in the final year of the loan if the Interest-Only Period is extended). In accordance with FASB ASC Topic 470-50, Debt – Modifications and Extinguishments, the Company evaluated the Amended Loan Agreement to determine whether it should be accounted for as a modification or extinguishment. As a result of this analysis, the Amended Loan Agreement was accounted for as a modification. Accordingly, no gain or loss is recognized. Approximately $ 0.1 million of fees paid to the lender were capitalized and will be amortized over the term of the Amended Loan Agreement. Expenses paid to third parties associated with the Amended Loan Agreement were immediately expensed and recorded in the Interest expense line item in our condensed consolidated statement of operations. Summary of Carrying Value The following table summarizes the components of the long-term debt carrying value, which approximates the fair value (in thousands): Future minimum payments due during the year ended December 31, September 30, 2022 December 31, 2021 2022 $ — $ 8,333 2023 — 18,167 2024 — — 2025 — — 2026 17,667 — 2027 9,562 — Total future minimum payments 27,229 26,500 Unamortized end of term charge ( 668 ) ( 694 ) Debt issuance costs ( 506 ) ( 85 ) Debt discount related to warrants ( 45 ) ( 65 ) Total debt 26,010 25,656 Current portion of long-term debt — ( 8,333 ) Long-term debt $ 26,010 $ 17,323 |
Fair Value Measurements
Fair Value Measurements | 9 Months Ended |
Sep. 30, 2022 | |
Fair Value Disclosures [Abstract] | |
Fair Value Measurements | 7. 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. In accordance with ASU 2017-04, Intangibles – Goodwill and Other (Topic 350) , the Company utilizes a two-step method, which allows the Company to first assess qualitative factors before performing a quantitative assessment of the fair value of a reporting unit. If it is determined on the basis of qualitative factors that the fair value of the IPR&D is more likely than not less than the carrying value, a quantitative impairment test is required. For the nine months ended September 30, 2022 and 2021, the Company performed an impairment analysis and concluded that there were no factors that triggered any impairment indicators. During the nine months ended September 30, 2022 and 2021, the Company experienced a decrease of approximately $ 1.5 million and $ 0.7 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. The fair value of these instruments as of September 30, 2022 and December 31, 2021 was as follows (in thousands): Quoted Prices in Significant Significant Total As of September 30, 2022 Cash equivalents: U.S. Treasury money market funds $ 118,705 $ — $ — $ 118,705 Short-term investments: U.S. government securities 8,038 — — 8,038 Commercial paper — 6,198 — 6,198 As of December 31, 2021 Cash equivalents: U.S. Treasury money market funds $ 30,853 $ — $ — $ 30,853 Short-term investments: U.S. government securities 12,190 — — 12,190 Asset backed securities — 11,346 — 11,346 Corporate securities — 49,066 — 49,066 Commercial paper — 54,557 — 54,557 |
Shareholders' Equity
Shareholders' Equity | 9 Months Ended |
Sep. 30, 2022 | |
Equity [Abstract] | |
Shareholders' Equity | 8. 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 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 “2021 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 2021 Pre-Funded Warrants did not contain any settlement obligations that would result in liability classification under ASC 480, Distinguishing Liability from Equity and ASC 815-40, Contracts in Entity’s Own Equity. The shares encompassed in the 2021 Pre-Funded Warrants were sold at the same price as the underlying common stock, less $ 0.001 (which represents the exercise price of the warrants). The Public Offering resulted in net proceeds to the Company of approximately $ 122.2 million, after deducting final underwriting discounts, commissions and offering expenses, as follows (in thousands): Financial instruments Proceeds Common stock $ 83,346 2021 Pre-funded Warrants 46,622 Total 129,968 Offering expenses ( 7,737 ) Net proceeds $ 122,231 The Company has used, and intends to continue to use, the net proceeds from the Public Offering to fund the clinical development of molgramostim for the treatment of aPAP and other general corporate purposes. Milestone Warrants 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. On March 15, 2021, 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. The warrant repurchase was accounted for as an equity transaction and resulted in a reduction to Additional paid-in capital in the condensed consolidated statement of stockholders’ equity. On August 13, 2021, thirty days following the achievement of a defined clinical milestone, the remaining 3,474,902 milestone warrants dated December 24, 2019, expired and therefore such milestone warrants have been terminated and are no longer outstanding or exercisable . Termination of Wainwright 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 subsequently amended on June 29, 2018 (the “Wainwright Sales Agreement”), pursuant to which the Company could offer and sell, from time to time, through Wainwright, shares of common stock having an aggregate offering price of not more than $ 60.0 million, in addition to the $ 2.3 million in shares sold prior to the amendment. The Company terminated the Wainwright Sales Agreement effective July 12, 2021 . Evercore 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 “Evercore Sales Agreement”), pursuant to which the Company may offer and sell, from time to time, through Evercore, shares of common stock (the “Shares”), having an aggregate offering price of not more than $ 60.0 million. The Evercore Sales Agreement was effective on July 16, 2021 , the date the Company’s shelf registration agreement on Form S-3, as filed with the SEC on July 6, 2021 (the "New Registration Statement"), was declared effective by the SEC. The Shares will be offered and sold pursuant to the New Registration Statement. Subject to the terms and conditions of the Evercore Sales Agreement, Evercore will use 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 Evercore 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 Evercore Sales Agreement or terminate the Evercore Sales Agreement. During the nine months ended September 30, 2022 and 2021, the Company did no t sell any shares of common stock under either the Wainwright Sales Agreement or the Evercore Sales Agreement. Common Stock Reserved for Issuance The Company’s shares of common stock reserved for issuance as of the periods indicated were as follows: September 30, 2022 December 31, 2021 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 2021 Pre-funded Warrants 32,175,172 32,175,172 Stock options outstanding 5,851,153 6,218,841 Issued and nonvested RSUs 1,090,062 1,272,375 Total shares reserved 45,749,717 46,299,718 Warrants The following table summarizes the outstanding warrants for the Company’s common stock as of September 30, 2022: Expiration Date Shares Underlying 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 37,955,709 $ 0.001 38,808,502 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, 2020 $ 941 $ 1 $ 942 Change ( 887 ) ( 50 ) ( 937 ) Balance, December 31, 2021 54 $ ( 49 ) 5 Change ( 1,621 ) 9 ( 1,612 ) Balance, September 30, 2022 $ ( 1,567 ) $ ( 40 ) $ ( 1,607 ) |
Commitments
Commitments | 9 Months Ended |
Sep. 30, 2022 | |
Commitments and Contingencies Disclosure [Abstract] | |
Commitments | 9. 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, the Company 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 the Company 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, the Company 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. 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): September 30, 2022 Molgramostim manufacturer: Achievement of certain milestones related to validation of API and regulatory approval of $ 2,600 Molgramostim nebulizer manufacturer: Achievement of various development activities and regulatory approval of nebulizer utilized 490 Total manufacturing and other commitments $ 3,090 The milestone commitments disclosed above reflect the activities that have no t been recognized at September 30, 2022 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, which manufactures the drug product from bulk vancomycin powder. 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 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, pass-through expenses, and investigator fees estimated to be approximately $ 34.0 million o ver 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 | 9 Months Ended |
Sep. 30, 2022 | |
Share-Based Payment Arrangement [Abstract] | |
Stock-Based Compensation | 10. Stock-Based Compensation 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. Amended and Restated 2015 Omnibus Incentive Option Plan The Company operates the Amended and Restated 2015 Omnibus Incentive Plan, as amended with approval by the Company's stockholders (the “2015 Plan”). 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 (“RSUs”), performance units, shares, and other stock-based awards. Share-based awards are subject to terms and conditions established by the board of directors or the compensation committee of the board of directors. As of September 30, 2022 , the number of shares of common stock available for grant under the 2015 Plan was 4,787,300 shares. Under both the 2008 Plan and 2015 Plan, stock options typically vest quarterly over four years and expire ten years from the grant date and RSUs typically vest quarterly over four years or cliff vest after two years. 2021 Inducement Equity Incentive Plan The Company adopted the 2021 Inducement Equity Incentive Plan in May 2021 and amended it in September 2021 and September 2022 (as amended, the “Inducement Plan”). 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 September 30, 2022 , the number of shares of common stock available for grant under the Inducement Plan was 935,000 shares. Under the Inducement Plan, stock options typically vest quarterly over four years and expire ten years from the grant date and RSUs typically cliff vest after two years . Stock-Based Awards Activity The following table provides a summary of stock-based awards activity for the nine months ended September 30, 2022: Stock Options: Outstanding at December 31, 2021 6,218,841 Granted 285,000 Exercised — Expired/cancelled/forfeited ( 652,688 ) Outstanding at September 30, 2022 5,851,153 The total compensation cost related to non-vested stock options not yet recognized as of September 30, 2022 , was $ 2.3 million, which will be recognized over a weighted-average period of approximately 2.5 years . RSUs: Outstanding at December 31, 2021 1,272,375 Granted 75,000 Vested ( 7,313 ) Forfeited ( 250,000 ) Outstanding at September 30, 2022 1,090,062 The total compensation cost related to unvested RSUs not yet recognized as of September 30, 2022 , was $ 0.8 million, which will be recognized over a weighted-average period of approximately 1.3 years . 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 nine months ended September 30, 2022 and 2021 (in thousands): Three months ended September 30, Nine months ended September 30, 2022 2021 2022 2021 Research and development $ 62 $ 175 $ 309 $ 930 General and administrative 388 515 1,171 1,477 Total stock-based compensation $ 450 $ 690 $ 1,480 $ 2,407 |
Net Loss Per Share
Net Loss Per Share | 9 Months Ended |
Sep. 30, 2022 | |
Earnings Per Share [Abstract] | |
Net Loss Per Share | 11. 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: Nine months ended September 30, 2022 2021 Awards under equity incentive plan 5,851,153 4,978,725 Non-vested restricted shares and restricted stock units 1,090,062 528,334 Warrants to purchase common stock 77,793 77,793 Total 7,019,008 5,584,852 The following table calculates basic earnings per share of common stock and diluted earnings per share of common stock for the three and nine months ended September 30, 2022 and 2021 (in thousands, except share and per share amounts): Three months ended September 30, Nine months ended September 30, 2022 2021 2022 2021 Net loss $ ( 10,386 ) $ ( 10,546 ) $ ( 27,850 ) $ ( 31,704 ) Net loss attributable to common ( 10,386 ) ( 10,546 ) ( 27,850 ) ( 31,704 ) Undistributed earnings and net loss ( 10,386 ) ( 10,546 ) ( 27,850 ) ( 31,704 ) Weighted-average common shares 152,773,015 152,587,848 152,771,302 127,623,824 Basic and diluted EPS $ ( 0.07 ) $ ( 0.07 ) $ ( 0.18 ) $ ( 0.25 ) |
Subsequent Events
Subsequent Events | 9 Months Ended |
Sep. 30, 2022 | |
Subsequent Events [Abstract] | |
Subsequent Events | 12. Subsequent Event s The Company has evaluated subsequent events through the date these condensed consolidated financial statements were issued. The Company determined there were no events that required disclosure or recognition in these condensed consolidated financial statements. |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Policies) | 9 Months Ended |
Sep. 30, 2022 | |
Accounting Policies [Abstract] | |
Basis of Presentation | Basis of Presentation The unaudited 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, 2022 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, 2021 . The Company’s significant accounting policies are described in Note 2 to the audited consolidated financial statements. There have been no changes to the Company's significant accounting policies since the date of those financial statements. |
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 (loss) income in the condensed consolidated balance sheet. All intercompany transactions and accounts have been eliminated in consolidation. The condensed consolidated balance sheet at December 31, 2021 has been derived from the Company's audited consolidated financial statements at that date but does not include all of the information and notes required by U.S. GAAP for complete financial statements. |
Liquidity | Liquidity As of September 30, 2022, the Company had an accumulated deficit of approximately $ 328.4 million. The Company used cash in operating activities of approximately $ 25.9 million during the nine months ended September 30, 2022. 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 for the treatment of aPAP 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. The Company intends to cover its future operating expenses through cash and cash equivalents on hand, short-term investments and, potentially, through a combination of equity offerings, debt financings, government or other third-party funding, and other collaborations and strategic alliances with partner companies. The Company cannot be sure that additional financing will be available when needed or that, if available, financing will be obtained on terms favorable to the Company or its stockholders. The Company’s cash and cash equivalents of $ 119.8 million and short-term investments of $ 14.2 million as of September 30, 2022 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, but are not limited to, those related to the accrual of research and development expenses and general and administrative costs, certain financial instruments recorded at fair value, the valuation of stock-based compensation, and the valuation allowance for deferred tax assets. The Company bases its estimates on historical experience, changes in circumstance and facts, 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. 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. The Company's 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 There are no recent accounting pronouncements issued by the FASB, the AICPA, or the SEC that are believed by the Company's 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) | 9 Months Ended |
Sep. 30, 2022 | |
Prepaid Expense and Other Assets, Current [Abstract] | |
Schedule of Prepaid Expenses and Other Current Assets | Prepaid expenses and other current assets consisted of the following (in thousands): September 30, 2022 December 31, 2021 Prepaid contracted research and development costs $ 1,789 $ 1,902 R&D tax credit receivable 725 838 VAT receivable 136 306 Prepaid insurance 240 427 Deposits and other 102 356 Total prepaid expenses and other current assets $ 2,992 $ 3,829 |
Accrued Expenses and Other Cu_2
Accrued Expenses and Other Current Liabilities (Tables) | 9 Months Ended |
Sep. 30, 2022 | |
Payables and Accruals [Abstract] | |
Summary of Accrued Expenses and Other Current Liabilities | Accrued expenses and other current liabilities consisted of (in thousands): September 30, 2022 December 31, 2021 Accrued contracted research and development costs $ 2,066 $ 1,623 Accrued compensation 1,615 2,526 Accrued general and administrative costs 507 600 Lease liability 82 135 Total accrued expenses and other current liabilities $ 4,270 $ 4,884 |
Short-term Investments (Tables)
Short-term Investments (Tables) | 9 Months Ended |
Sep. 30, 2022 | |
Investments, Debt and Equity Securities [Abstract] | |
Summary of Major Security Type of 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 September 30, 2022 Amortized Cost Gross Unrealized Gains Gross Unrealized Losses Fair Value Short-term investments U.S. government securities $ 8,078 $ — $ ( 40 ) $ 8,038 Commercial paper 6,198 — — 6,198 Total short-term investments $ 14,276 $ — $ ( 40 ) $ 14,236 As of December 31, 2021 Amortized Cost Gross Unrealized Gains Gross Unrealized Losses Fair Value Short-term investments U.S. government securities $ 12,205 $ — $ ( 15 ) $ 12,190 Asset backed securities 11,349 — ( 3 ) 11,346 Corporate securities 49,095 — ( 29 ) 49,066 Commercial paper 54,557 — — 54,557 Total short-term investments $ 127,206 $ — $ ( 47 ) $ 127,159 |
Long-term Debt (Tables)
Long-term Debt (Tables) | 9 Months Ended |
Sep. 30, 2022 | |
Debt Disclosure [Abstract] | |
Carrying Value and Future Minimum Payments | The following table summarizes the components of the long-term debt carrying value, which approximates the fair value (in thousands): Future minimum payments due during the year ended December 31, September 30, 2022 December 31, 2021 2022 $ — $ 8,333 2023 — 18,167 2024 — — 2025 — — 2026 17,667 — 2027 9,562 — Total future minimum payments 27,229 26,500 Unamortized end of term charge ( 668 ) ( 694 ) Debt issuance costs ( 506 ) ( 85 ) Debt discount related to warrants ( 45 ) ( 65 ) Total debt 26,010 25,656 Current portion of long-term debt — ( 8,333 ) Long-term debt $ 26,010 $ 17,323 |
Fair Value Measurements (Tables
Fair Value Measurements (Tables) | 9 Months Ended |
Sep. 30, 2022 | |
Fair Value Disclosures [Abstract] | |
Summary of Fair Value of Financial Instruments | The fair value of these instruments as of September 30, 2022 and December 31, 2021 was as follows (in thousands): Quoted Prices in Significant Significant Total As of September 30, 2022 Cash equivalents: U.S. Treasury money market funds $ 118,705 $ — $ — $ 118,705 Short-term investments: U.S. government securities 8,038 — — 8,038 Commercial paper — 6,198 — 6,198 As of December 31, 2021 Cash equivalents: U.S. Treasury money market funds $ 30,853 $ — $ — $ 30,853 Short-term investments: U.S. government securities 12,190 — — 12,190 Asset backed securities — 11,346 — 11,346 Corporate securities — 49,066 — 49,066 Commercial paper — 54,557 — 54,557 |
Shareholders' Equity (Tables)
Shareholders' Equity (Tables) | 9 Months Ended |
Sep. 30, 2022 | |
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 $ 122.2 million, after deducting final underwriting discounts, commissions and offering expenses, as follows (in thousands): Financial instruments Proceeds Common stock $ 83,346 2021 Pre-funded Warrants 46,622 Total 129,968 Offering expenses ( 7,737 ) Net proceeds $ 122,231 |
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: September 30, 2022 December 31, 2021 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 2021 Pre-funded Warrants 32,175,172 32,175,172 Stock options outstanding 5,851,153 6,218,841 Issued and nonvested RSUs 1,090,062 1,272,375 Total shares reserved 45,749,717 46,299,718 |
Summary of Outstanding Warrants for Company's Common Stock | The following table summarizes the outstanding warrants for the Company’s common stock as of September 30, 2022: Expiration Date Shares Underlying 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 37,955,709 $ 0.001 38,808,502 |
Components of Accumulated Other Comprehensive Income (Loss) | 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, 2020 $ 941 $ 1 $ 942 Change ( 887 ) ( 50 ) ( 937 ) Balance, December 31, 2021 54 $ ( 49 ) 5 Change ( 1,621 ) 9 ( 1,612 ) Balance, September 30, 2022 $ ( 1,567 ) $ ( 40 ) $ ( 1,607 ) |
Commitments (Tables)
Commitments (Tables) | 9 Months Ended |
Sep. 30, 2022 | |
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): September 30, 2022 Molgramostim manufacturer: Achievement of certain milestones related to validation of API and regulatory approval of $ 2,600 Molgramostim nebulizer manufacturer: Achievement of various development activities and regulatory approval of nebulizer utilized 490 Total manufacturing and other commitments $ 3,090 |
Stock-Based Compensation (Table
Stock-Based Compensation (Tables) | 9 Months Ended |
Sep. 30, 2022 | |
Share-Based Payment Arrangement [Abstract] | |
Summary of Stock-based Awards Activity Under the 2008 Plan, 2015 Plan and Inducement Plan | The following table provides a summary of stock-based awards activity for the nine months ended September 30, 2022: Stock Options: Outstanding at December 31, 2021 6,218,841 Granted 285,000 Exercised — Expired/cancelled/forfeited ( 652,688 ) Outstanding at September 30, 2022 5,851,153 The total compensation cost related to non-vested stock options not yet recognized as of September 30, 2022 , was $ 2.3 million, which will be recognized over a weighted-average period of approximately 2.5 years . RSUs: Outstanding at December 31, 2021 1,272,375 Granted 75,000 Vested ( 7,313 ) Forfeited ( 250,000 ) Outstanding at September 30, 2022 1,090,062 |
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 nine months ended September 30, 2022 and 2021 (in thousands): Three months ended September 30, Nine months ended September 30, 2022 2021 2022 2021 Research and development $ 62 $ 175 $ 309 $ 930 General and administrative 388 515 1,171 1,477 Total stock-based compensation $ 450 $ 690 $ 1,480 $ 2,407 |
Net Loss Per Share (Tables)
Net Loss Per Share (Tables) | 9 Months Ended |
Sep. 30, 2022 | |
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: Nine months ended September 30, 2022 2021 Awards under equity incentive plan 5,851,153 4,978,725 Non-vested restricted shares and restricted stock units 1,090,062 528,334 Warrants to purchase common stock 77,793 77,793 Total 7,019,008 5,584,852 |
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 nine months ended September 30, 2022 and 2021 (in thousands, except share and per share amounts): Three months ended September 30, Nine months ended September 30, 2022 2021 2022 2021 Net loss $ ( 10,386 ) $ ( 10,546 ) $ ( 27,850 ) $ ( 31,704 ) Net loss attributable to common ( 10,386 ) ( 10,546 ) ( 27,850 ) ( 31,704 ) Undistributed earnings and net loss ( 10,386 ) ( 10,546 ) ( 27,850 ) ( 31,704 ) Weighted-average common shares 152,773,015 152,587,848 152,771,302 127,623,824 Basic and diluted EPS $ ( 0.07 ) $ ( 0.07 ) $ ( 0.18 ) $ ( 0.25 ) |
Organization and Nature of Op_2
Organization and Nature of Operations - Additional Information (Detail) | 9 Months Ended |
Sep. 30, 2022 USD ($) 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 | 9 Months Ended | ||
Sep. 30, 2022 USD ($) Segment | Sep. 30, 2021 USD ($) | Dec. 31, 2021 USD ($) | |
Summary Of Significant Accounting Policies [Line Items] | |||
Accumulated deficit | $ (328,371) | $ (300,521) | |
Cash in operating activities | (25,903) | $ (30,718) | |
Cash and cash equivalents | 119,841 | 34,012 | |
Short-term investments | $ 14,236 | $ 127,159 | |
Number of operating segments | Segment | 1 |
Prepaid Expenses and Other Cu_3
Prepaid Expenses and Other Current Assets - Summary of Prepaid Expenses and Other Current Assets (Detail) - USD ($) $ in Thousands | Sep. 30, 2022 | Dec. 31, 2021 |
Prepaid Expense and Other Assets, Current [Abstract] | ||
Prepaid contracted research and development costs | $ 1,789 | $ 1,902 |
R&D tax credit receivable | 725 | 838 |
VAT receivable | 136 | 306 |
Prepaid insurance | 240 | 427 |
Deposits and other | 102 | 356 |
Total prepaid expenses and other current assets | $ 2,992 | $ 3,829 |
Prepaid Expenses and Other Cu_4
Prepaid Expenses and Other Current Assets - Additional Information (Detail) - Savara ApS [Member] - USD ($) $ in Millions | 9 Months Ended | |
Sep. 30, 2022 | Dec. 31, 2021 | |
Prepaid Expenses And Other Current Assets [Line Items] | ||
Research and development tax credits | 22% | |
Prepaid Expenses and Other Current Assets [Member] | ||
Prepaid Expenses And Other Current Assets [Line Items] | ||
Research and development tax credits receivable | $ 0.7 | |
Other Non-current Assets [Member] | ||
Prepaid Expenses And Other Current Assets [Line Items] | ||
Research and development tax credits receivable | $ 0.7 |
Accrued Expenses and Other Cu_3
Accrued Expenses and Other Current Liabilities - Summary of Accrued Expenses and Other Current Liabilities (Detail) - USD ($) $ in Thousands | Sep. 30, 2022 | Dec. 31, 2021 |
Payables and Accruals [Abstract] | ||
Accrued contracted research and development costs | $ 2,066 | $ 1,623 |
Accrued compensation | 1,615 | 2,526 |
Accrued general and administrative costs | 507 | 600 |
Lease liability | 82 | 135 |
Total accrued expenses and other current liabilities | $ 4,270 | $ 4,884 |
Short-term Investments - Summar
Short-term Investments - Summary of Major Security and Type of Investments (Detail) - USD ($) $ in Thousands | Sep. 30, 2022 | Dec. 31, 2021 |
Schedule Of Available For Sale Securities [Line Items] | ||
Amortized Cost | $ 14,276 | $ 127,206 |
Gross Unrealized Losses | (40) | (47) |
Fair Value | 14,236 | 127,159 |
U.S. Government Securities [Member] | ||
Schedule Of Available For Sale Securities [Line Items] | ||
Amortized Cost | 8,078 | 12,205 |
Gross Unrealized Losses | (40) | (15) |
Fair Value | 8,038 | 12,190 |
Asset Backed Securities [Member] | ||
Schedule Of Available For Sale Securities [Line Items] | ||
Amortized Cost | 11,349 | |
Gross Unrealized Losses | (3) | |
Fair Value | 11,346 | |
Corporate Securities [Member] | ||
Schedule Of Available For Sale Securities [Line Items] | ||
Amortized Cost | 49,095 | |
Gross Unrealized Losses | (29) | |
Fair Value | 49,066 | |
Commercial Paper [Member] | ||
Schedule Of Available For Sale Securities [Line Items] | ||
Amortized Cost | 6,198 | 54,557 |
Fair Value | $ 6,198 | $ 54,557 |
Short-term Investments - Additi
Short-term Investments - Additional Information (Detail) - USD ($) | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2022 | Sep. 30, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | |
Investments, Debt and Equity Securities [Abstract] | ||||
Realized gains or losses on investments | $ 0 | $ 0 | $ 0 | $ 0 |
Long-term Debt - Additional Inf
Long-term Debt - Additional Information (Detail) - USD ($) | 9 Months Ended | ||
Apr. 21, 2022 | Apr. 28, 2017 | Sep. 30, 2022 | |
Debt Instrument [Line Items] | |||
Repayment of outstanding amounts under Loan Agreement | $ 26,350,000 | ||
Loan and Security Agreement [Member] | Silicon Valley Bank [Member] | |||
Debt Instrument [Line Items] | |||
Loan agreement amendment date | Oct. 31, 2017 | ||
Loan agreement amendment date one | Dec. 04, 2018 | ||
Loan agreement amendment date two | Jan. 31, 2020 | ||
Loan agreement amendment date three | Mar. 30, 2021 | ||
Loan and Security Agreement [Member] | Silicon Valley Bank [Member] | Term Loan [Member] | |||
Debt Instrument [Line Items] | |||
Loan agreement amendment date | Apr. 21, 2022 | ||
Principal amount | $ 26,500,000 | $ 25,000,000 | |
Repayment of outstanding amounts under Loan Agreement | 25,000,000 | ||
Prepayment fee | 100,000 | ||
Payment of debt issuance cost | $ 100,000 | ||
End of term charge | $ 1,400,000 | ||
Percentage of obligation to pay closing fees and final payment | 2.75% | ||
Debt instrument payment description | Pursuant to the Amended Loan Agreement, the loan has an interest-only monthly payment through April 21, 2026 (the “Interest-Only Period”) and thereafter equal monthly installments of principal plus interest over 12 months until April 21, 2027 (the “Maturity Date”). However, the Company may elect to extend the Interest-Only Period until the Maturity Date if it maintains cash and cash equivalents equal to at least 1.75 times the outstanding principal amount of the loan during the fifth year. If the Interest-Only Period is extended, all principal and unpaid interest is due and payable on the Maturity Date | ||
Debt instrument principal and interest payment period | 12 months | ||
Debt instrument, maturity rate range, end | Apr. 21, 2027 | ||
Interest only extension cash percentage of outstanding principal | 1.75% | ||
Frequency of principal plus interest repayment period | equal monthly installments | ||
Interest rate, basis spread | 0.50% | ||
Debt instrument, interest rate | 3% | ||
Extinguishment Of Debt | $ 0 | ||
Loan and Security Agreement [Member] | Silicon Valley Bank [Member] | Term Loan [Member] | Maximum [Member] | |||
Debt Instrument [Line Items] | |||
Debt instrument covenants cash and cash equivalents threshold limit | $ 40,000,000 | ||
Loan and Security Agreement [Member] | Silicon Valley Bank [Member] | Term Loan [Member] | Before First Anniversary Closing Date [Member} | |||
Debt Instrument [Line Items] | |||
Prepayment fee percentage | 4.25% | ||
Loan and Security Agreement [Member] | Silicon Valley Bank [Member] | Term Loan [Member] | After First And Before Second Anniversary Closing Date | |||
Debt Instrument [Line Items] | |||
Prepayment fee percentage | 1% |
Long-term Debt - Carrying Value
Long-term Debt - Carrying Value and Future Minimum Payments (Detail) - USD ($) $ in Thousands | Sep. 30, 2022 | Dec. 31, 2021 |
Debt Disclosure [Abstract] | ||
2022 | $ 8,333 | |
2023 | 18,167 | |
2026 | $ 17,667 | |
2027 | 9,562 | |
Total future minimum payments | 27,229 | 26,500 |
Unamortized end of term charge | (668) | (694) |
Debt issuance costs | (506) | (85) |
Debt discount related to warrants | (45) | (65) |
Total debt | 26,010 | 25,656 |
Current portion of long-term debt | (8,333) | |
Long-term debt | $ 26,010 | $ 17,323 |
Fair Value Measurements - Addit
Fair Value Measurements - Additional Information (Detail) - USD ($) $ in Millions | 9 Months Ended | |
Sep. 30, 2022 | Sep. 30, 2021 | |
Fair Value Disclosures [Abstract] | ||
Increase decrease in carrying value of IPR&D due to foreign currency translation | $ (1.5) | $ (0.7) |
Fair Value Measurements - Summa
Fair Value Measurements - Summary of Fair Value of Financial Instruments (Detail) - Fair Value, Measurements, Recurring [Member] - USD ($) $ in Thousands | Sep. 30, 2022 | Dec. 31, 2021 |
U.S. Treasury Money Market Funds [Member] | ||
Cash equivalents: | ||
Cash equivalents | $ 118,705 | $ 30,853 |
U.S. Government Securities [Member] | ||
Short-term investments: | ||
Short-term investments | 8,038 | 12,190 |
Asset Backed Securities [Member] | ||
Short-term investments: | ||
Short-term investments | 11,346 | |
Corporate Securities [Member] | ||
Short-term investments: | ||
Short-term investments | 49,066 | |
Commercial Paper [Member] | ||
Short-term investments: | ||
Short-term investments | 6,198 | 54,557 |
Quoted Prices in Active Markets for Identical Assets (Level 1) [Member] | U.S. Treasury Money Market Funds [Member] | ||
Cash equivalents: | ||
Cash equivalents | 118,705 | 30,853 |
Quoted Prices in Active Markets for Identical Assets (Level 1) [Member] | U.S. Government Securities [Member] | ||
Short-term investments: | ||
Short-term investments | 8,038 | 12,190 |
Significant Other Observable Inputs (Level 2) [Member] | Asset Backed Securities [Member] | ||
Short-term investments: | ||
Short-term investments | 11,346 | |
Significant Other Observable Inputs (Level 2) [Member] | Corporate Securities [Member] | ||
Short-term investments: | ||
Short-term investments | 49,066 | |
Significant Other Observable Inputs (Level 2) [Member] | Commercial Paper [Member] | ||
Short-term investments: | ||
Short-term investments | $ 6,198 | $ 54,557 |
Shareholders' Equity - Addition
Shareholders' Equity - Additional Information (Detail) - USD ($) | 3 Months Ended | 9 Months Ended | |||||||||||||
Aug. 13, 2021 | Jul. 16, 2021 | Jul. 12, 2021 | Mar. 15, 2021 | Mar. 05, 2021 | Jun. 28, 2018 | Jun. 30, 2021 | Mar. 31, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | Dec. 31, 2021 | Jul. 06, 2021 | Apr. 28, 2017 | |||
Class Of Warrant Or Right [Line Items] | |||||||||||||||
Common stock, par value | $ 0.001 | $ 0.001 | |||||||||||||
Net proceeds after deducting underwriting discounts commissions and offering expenses | $ 122,231,000 | ||||||||||||||
Value of shares sold prior to amendment | $ 321,000 | $ 121,827,000 | [1] | ||||||||||||
H.C. Wainwright & Co., LLC [Member] | |||||||||||||||
Class Of Warrant Or Right [Line Items] | |||||||||||||||
Common stock, shares sold | 0 | 0 | |||||||||||||
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 | $ 60,000,000 | ||||||||||||||
Evercore Group L.L.C., [Member] | |||||||||||||||
Class Of Warrant Or Right [Line Items] | |||||||||||||||
Common stock, shares sold | 0 | 0 | |||||||||||||
Sales commissions in fixed percentage of gross proceeds per share | 3% | ||||||||||||||
Common stock sales agreement, effective date | Jul. 16, 2021 | ||||||||||||||
Evercore Group L.L.C., [Member] | Maximum [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 | ||||||||||||||
Warrants and rights outstanding | $ 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 | ||||||||||||||
Number of warrants expired | 3,474,902 | ||||||||||||||
Common Stock [Member] | |||||||||||||||
Class Of Warrant Or Right [Line Items] | |||||||||||||||
Value of shares sold prior to amendment | [1] | $ 57,000 | |||||||||||||
Common Stock [Member] | H.C. Wainwright & Co., LLC [Member] | |||||||||||||||
Class Of Warrant Or Right [Line Items] | |||||||||||||||
Value of shares sold prior to amendment | $ 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 | 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 | $ 122,200,000 | ||||||||||||||
[1] As discussed in Note 8. Stockholders’ Equity , the Company sold (i) an aggregate of 57,479,978 shares of the Company’s common stock, par value $ 0.001 per share and (ii) pre-funded warrants to purchase an aggregate of 32,175,172 shares of the Company's common stock at an exercise price, equal to the par value, of $ 0.001 per share. |
Shareholders' Equity - Summary
Shareholders' Equity - Summary of Net Proceeds after Deducting Underwriting Discounts Commissions and Offering Expenses (Detail) $ in Thousands | Mar. 15, 2021 USD ($) |
Class Of Warrant Or Right [Line Items] | |
Total common stock and pre-funded warrants | $ 129,968 |
Offering expenses | (7,737) |
Net proceeds | 122,231 |
Common Stock [Member] | |
Class Of Warrant Or Right [Line Items] | |
Total common stock and pre-funded warrants | 83,346 |
2021 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 | Sep. 30, 2022 | Dec. 31, 2021 |
Class Of Warrant Or Right [Line Items] | ||
Total shares reserved | 45,749,717 | 46,299,718 |
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 |
2021 Pre-funded Warrants [Member] | ||
Class Of Warrant Or Right [Line Items] | ||
Total shares reserved | 32,175,172 | 32,175,172 |
Stock Options Outstanding [Member] | ||
Class Of Warrant Or Right [Line Items] | ||
Total shares reserved | 5,851,153 | 6,218,841 |
Issued and nonvested RSUs [Member] | ||
Class Of Warrant Or Right [Line Items] | ||
Total shares reserved | 1,090,062 | 1,272,375 |
Shareholders' Equity - Summar_2
Shareholders' Equity - Summary of Outstanding Warrants for Company's Common Stock (Detail) | 9 Months Ended |
Sep. 30, 2022 $ / shares shares | |
Class Of Warrant Or Right [Line Items] | |
Shares Underlying Outstanding Warrants | 38,808,502 |
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 | 37,955,709 |
Exercise Price | $ / shares | $ 0.001 |
Expiration Date | None |
Shareholders' Equity - Componen
Shareholders' Equity - Components of Accumulated Other Comprehensive Income (Loss) (Detail) - USD ($) $ in Thousands | 9 Months Ended | 12 Months Ended |
Sep. 30, 2022 | Dec. 31, 2021 | |
Accumulated Other Comprehensive Income Loss [Line Items] | ||
Total Accumulated Other Comprehensive Income (Loss) | $ 5 | $ 942 |
Change | (1,612) | (937) |
Total Accumulated Other Comprehensive Income (Loss) | (1,607) | 5 |
Foreign Exchange Translation Adjustment [Member] | ||
Accumulated Other Comprehensive Income Loss [Line Items] | ||
Total Accumulated Other Comprehensive Income (Loss) | 54 | 941 |
Change | (1,621) | (887) |
Total Accumulated Other Comprehensive Income (Loss) | (1,567) | 54 |
Unrealized Gain (Loss) on ST Investments [Member] | ||
Accumulated Other Comprehensive Income Loss [Line Items] | ||
Total Accumulated Other Comprehensive Income (Loss) | (49) | 1 |
Change | 9 | (50) |
Total Accumulated Other Comprehensive Income (Loss) | $ (40) | $ (49) |
Commitments - Additional Inform
Commitments - Additional Information (Detail) - USD ($) | 9 Months Ended | |
Mar. 05, 2021 | Sep. 30, 2022 | |
Commitments And Contingencies [Line Items] | ||
Contingent milestones commitments recognized | $ 0 | |
Estimated service fees, pass through expenses, and investigator fees | $ 34,000,000 | |
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, the Company 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 the Company 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, the Company 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 | 9 Months Ended |
Sep. 30, 2022 USD ($) | |
Commitments And Contingencies [Line Items] | |
Total manufacturing and other commitments | $ 3,090 |
Active Pharmaceutical Ingredients [Member] | |
Commitments And Contingencies [Line Items] | |
Achievement of certain milestones related to validation of API and regulatory approval of molgramostim | 2,600 |
Molgramostim Nebulizer Manufacturer [Member] | |
Commitments And Contingencies [Line Items] | |
Achievement of various development activities and regulatory approval of nebulizer utilized to administer molgramostim | $ 490 |
Stock-Based Compensation - Addi
Stock-Based Compensation - Additional Information (Detail) $ in Millions | 9 Months Ended |
Sep. 30, 2022 USD ($) shares | |
Stock Options [Member] | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |
Total compensation cost not yet recognized | $ | $ 2.3 |
Weighted-average period to be recognized | 2 years 6 months |
RSUs [Member] | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |
Total compensation cost not yet recognized | $ | $ 0.8 |
Weighted-average period to be recognized | 1 year 3 months 18 days |
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 |
Amended and Restated 2015 Omnibus Incentive Option Plan [Member] | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |
Common stock available for grant | 4,787,300 |
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 |
Contractual term | 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 |
Contractual term | 10 years |
2021 Inducement Equity Incentive Plan [Member] | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |
Common stock available for grant | 935,000 |
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 |
Contractual term | 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, 2015 Plan and Inducement Plan (Detail) | 9 Months Ended |
Sep. 30, 2022 shares | |
Share-Based Payment Arrangement [Abstract] | |
Stock Options, Outstanding at beginning balance | 6,218,841 |
Stock Options, Granted | 285,000 |
Stock Options, Exercised | 0 |
Stock Options, Forfeited | (652,688) |
Stock Options, Outstanding at ending balance | 5,851,153 |
RSUs, Outstanding at beginning balance | 1,272,375 |
RSUs, Granted | 75,000 |
RSUs, Vested | (7,313) |
RSUs, Forfeited | (250,000) |
RSUs, Outstanding at ending balance | 1,090,062 |
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 | 9 Months Ended | ||
Sep. 30, 2022 | Sep. 30, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | |
Employee Service Share Based Compensation Allocation Of Recognized Period Costs [Line Items] | ||||
Total stock-based compensation | $ 450 | $ 690 | $ 1,480 | $ 2,407 |
Research and Development [Member] | ||||
Employee Service Share Based Compensation Allocation Of Recognized Period Costs [Line Items] | ||||
Total stock-based compensation | 62 | 175 | 309 | 930 |
General and Administrative [Member] | ||||
Employee Service Share Based Compensation Allocation Of Recognized Period Costs [Line Items] | ||||
Total stock-based compensation | $ 388 | $ 515 | $ 1,171 | $ 1,477 |
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 | 9 Months Ended | |
Sep. 30, 2022 | Sep. 30, 2021 | |
Earnings Per Share Basic [Line Items] | ||
Anti-dilutive securities excluded from calculation of diluted net loss per share | 7,019,008 | 5,584,852 |
Awards under Equity Incentive Plan [Member] | ||
Earnings Per Share Basic [Line Items] | ||
Anti-dilutive securities excluded from calculation of diluted net loss per share | 5,851,153 | 4,978,725 |
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 | 1,090,062 | 528,334 |
Warrants to Purchase Common Stock [Member] | ||
Earnings Per Share Basic [Line Items] | ||
Anti-dilutive securities excluded from calculation of diluted net loss per share | 77,793 | 77,793 |
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 | 9 Months Ended | ||||||
Sep. 30, 2022 | Jun. 30, 2022 | Mar. 31, 2022 | Sep. 30, 2021 | Jun. 30, 2021 | Mar. 31, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | |
Earnings Per Share [Abstract] | ||||||||
Net loss | $ (10,386) | $ (9,164) | $ (8,300) | $ (10,546) | $ (10,941) | $ (10,217) | $ (27,850) | $ (31,704) |
Net loss attributable to common stockholders | (10,386) | (10,546) | (27,850) | (31,704) | ||||
Undistributed earnings and net loss attributable to common stockholders, basic and diluted | $ (10,386) | $ (10,546) | $ (27,850) | $ (31,704) | ||||
Weighted Average Number of Shares Outstanding, Basic | 152,773,015 | 152,587,848 | 152,771,302 | 127,623,824 | ||||
Weighted Average Number of Shares Outstanding, Diluted | 152,773,015 | 152,587,848 | 152,771,302 | 127,623,824 | ||||
Earnings Per Share, Basic | $ (0.07) | $ (0.07) | $ (0.18) | $ (0.25) | ||||
Earnings Per Share, Diluted | $ (0.07) | $ (0.07) | $ (0.18) | $ (0.25) |