Document and Entity Information
Document and Entity Information - USD ($) | 12 Months Ended | ||
Dec. 31, 2022 | Mar. 30, 2023 | Jun. 30, 2022 | |
Cover [Abstract] | |||
Document Type | 10-K | ||
Amendment Flag | false | ||
Document Period End Date | Dec. 31, 2022 | ||
Document Fiscal Year Focus | 2022 | ||
Document Fiscal Period Focus | FY | ||
Entity Registrant Name | Savara Inc. | ||
Entity Central Index Key | 0001160308 | ||
Current Fiscal Year End Date | --12-31 | ||
Entity Well-known Seasoned Issuer | No | ||
Entity Current Reporting Status | Yes | ||
Entity Interactive Data Current | Yes | ||
Entity Voluntary Filers | No | ||
Entity Filer Category | Non-accelerated Filer | ||
Entity Small Business | true | ||
Entity Emerging Growth Company | false | ||
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 1 | ||
Entity Address, Address Line Three | Suite 205 | ||
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 Annual Report | true | ||
Document Transition Report | false | ||
ICFR Auditor Attestation Flag | false | ||
Entity Incorporation, State or Country Code | DE | ||
Entity Common Stock, Shares Outstanding | 114,064,736 | ||
Entity Public Float | $ 159,286,465 | ||
Title of 12(b) Security | Common Stock, par value $0.001 per share | ||
Trading Symbol | SVRA | ||
Security Exchange Name | NASDAQ | ||
Documents Incorporated by Reference | Portions of the Registrant’s Definitive Proxy Statement relating to the Annual Meeting of Shareholders, scheduled to be held on June 8 , 2023, are incorporated by reference into Part III of this Report. | ||
Auditor Firm ID | 49 | ||
Auditor Location | Austin, Texas | ||
Auditor Name | RSM US LLP |
Consolidated Balance Sheets
Consolidated Balance Sheets - USD ($) $ in Thousands | Dec. 31, 2022 | Dec. 31, 2021 |
Current assets: | ||
Cash and cash equivalents | $ 52,100 | $ 34,012 |
Short-term investments | 73,776 | 127,159 |
Prepaid expenses and other current assets | 3,078 | 3,829 |
Total current assets | 128,954 | 165,000 |
Property and equipment, net | 51 | 73 |
In-process R&D | 10,656 | 11,274 |
Other non-current assets | 116 | 251 |
Total assets | 139,777 | 176,598 |
Current liabilities: | ||
Accounts payable | 1,334 | 1,443 |
Accrued expenses and other current liabilities | 4,533 | 4,884 |
Current portion of long-term debt | 8,333 | |
Total current liabilities | 5,867 | 14,660 |
Long-term liabilities: | ||
Long-term debt | 26,078 | 17,323 |
Other long-term liabilities | 54 | 117 |
Total liabilities | 31,999 | 32,100 |
Commitments and contingencies (Note 11) | ||
Stockholders’ equity: | ||
Common stock, $0.001 par value, 300,000,000 shares authorized as of December 31, 2022 and 2021, respectively; 114,046,345 and 114,036,892 shares issued and outstanding as of December 31, 2022 and 2021, respectively | 116 | 116 |
Additional paid-in capital | 446,938 | 444,898 |
Accumulated other comprehensive income (loss) | (605) | 5 |
Accumulated deficit | (338,671) | (300,521) |
Total stockholders’ equity | 107,778 | 144,498 |
Total liabilities and stockholders' equity | $ 139,777 | $ 176,598 |
Consolidated Balance Sheets (Pa
Consolidated Balance Sheets (Parenthetical) - $ / shares | Dec. 31, 2022 | Dec. 31, 2021 |
Statement of Financial Position [Abstract] | ||
Common stock, par value | $ 0.001 | $ 0.001 |
Common stock, shares authorized | 300,000,000 | 300,000,000 |
Common stock, shares issued | 114,046,345 | 114,036,892 |
Common stock, shares outstanding | 114,046,345 | 114,036,892 |
Consolidated Statements of Oper
Consolidated Statements of Operations and Comprehensive Loss - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Operating expenses: | ||
Research and development | $ 27,879 | $ 28,991 |
General and administrative | 10,929 | 12,350 |
Depreciation and amortization | 31 | 136 |
Total operating expenses | 38,839 | 41,477 |
Loss from operations | (38,839) | (41,477) |
Other income (expense), net: | ||
Interest expense, net | (88) | (2,282) |
Foreign currency exchange loss | (19) | (99) |
Tax credit income | 796 | 844 |
Total other income (expense), net | 689 | (1,537) |
Net loss | $ (38,150) | $ (43,014) |
Net loss per share: | ||
Basic | $ (0.25) | $ (0.32) |
Diluted | $ (0.25) | $ (0.32) |
Weighted average common shares outstanding: | ||
Basic | 152,771,817 | 133,919,145 |
Diluted | 152,771,817 | 133,919,145 |
Other comprehensive income (loss): | ||
Loss on foreign currency translation | $ (648) | $ (887) |
Unrealized gain (loss) on short-term investments | 38 | (50) |
Total comprehensive loss | $ (38,760) | $ (43,951) |
Consolidated Statements of Chan
Consolidated Statements of Changes in Stockholders' Equity - 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] | 122,231 | $ 57 | 122,174 | ||
Issuance of common stock and pre-funded warrants in public offering, net of offering costs,shares | [1] | 57,479,978 | ||||
Repurchase of outstanding pre-funded warrants | (3,909) | (3,909) | ||||
Issuance of common stock upon exercise of stock warrants, net | 2,546 | $ 2 | 2,544 | |||
Issuance of common stock upon exercise of stock warrants, net, shares | 1,737,450 | |||||
Issuance of common stock upon exercise of stock options | 16 | $ 1 | 15 | |||
Issuance of common stock upon exercise of stock options, shares | 285,576 | |||||
Issuance of common stock for settlement of RSUs | $ 1 | (1) | ||||
Issuance of common stock for settlement of RSUs, shares | 443,897 | |||||
Repurchase of shares for minimum tax withholdings | (78) | (78) | ||||
Repurchase of shares for minimum tax withholdings,shares | (62,964) | |||||
Stock-based compensation | 3,260 | 3,260 | ||||
Foreign exchange translation adjustment | (887) | (887) | ||||
Unrealized gain (loss) on short-term investments | (50) | (50) | ||||
Net loss | (43,014) | (43,014) | ||||
Ending balance at Dec. 31, 2021 | $ 144,498 | $ 116 | 444,898 | (300,521) | 5 | |
Ending balance, shares at Dec. 31, 2021 | 114,036,892 | 114,036,892 | ||||
Issuance of common stock upon exercise of stock options | $ 2 | 2 | ||||
Issuance of common stock upon exercise of stock options, shares | 2,344 | 2,344 | ||||
Issuance of common stock for settlement of RSUs, shares | 8,672 | 9,125 | ||||
Repurchase of shares for minimum tax withholdings | $ (3) | (3) | ||||
Repurchase of shares for minimum tax withholdings,shares | (2,016) | |||||
Stock-based compensation | 2,041 | 2,041 | ||||
Foreign exchange translation adjustment | (648) | (648) | ||||
Unrealized gain (loss) on short-term investments | 38 | 38 | ||||
Net loss | (38,150) | (38,150) | ||||
Ending balance at Dec. 31, 2022 | $ 107,778 | $ 116 | $ 446,938 | $ (338,671) | $ (605) | |
Ending balance, shares at Dec. 31, 2022 | 114,046,345 | 114,046,345 | ||||
[1] As discussed in Note 9. 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. |
Consolidated Statements of Ch_2
Consolidated Statements of Changes in Stockholders' Equity (Parenthetical) - $ / shares | Mar. 15, 2021 | Dec. 31, 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 | ||
Common Stock pre funded warrants exercise price | $ 0.001 |
Consolidated Statements of Cash
Consolidated Statements of Cash Flows - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2022 | Dec. 31, 2021 | ||
Cash flows from operating activities: | |||
Net loss | $ (38,150) | $ (43,014) | |
Adjustments to reconcile net loss to net cash used in operating activities: | |||
Depreciation and amortization | 31 | 136 | |
Amortization of right-of-use assets | 136 | 231 | |
Non-cash interest income | (103) | ||
Foreign currency loss | 19 | 99 | |
Amortization of debt issuance costs | 334 | 552 | |
Amortization on premium to short-term investments, net | 75 | 1,604 | |
Stock-based compensation | 2,041 | 3,260 | |
Changes in operating assets and liabilities: | |||
Prepaid expenses and other current assets | 1,336 | (1,039) | |
Non-current assets | (57) | ||
Accounts payable and accrued expenses and other current liabilities | (319) | (1,763) | |
Long-term liabilities | (44) | ||
Net cash used in operating activities | (34,554) | (40,081) | |
Cash flows from investing activities: | |||
Purchase of property and equipment | (9) | (57) | |
Purchase of available-for-sale securities, net | (89,415) | (161,069) | |
Maturity of available-for-sale securities | 130,793 | 83,470 | |
Sale of available-for-sale securities, net | 11,276 | 8,200 | |
Net cash provided by (used in) investing activities | 52,645 | (69,456) | |
Cash flows from financing activities: | |||
Repurchase of outstanding pre-funded warrants | (3,909) | ||
Repayment of long-term debt | [1] | (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 | 122,231 | ||
Issuance of common stock upon exercise of warrants, net | 2,546 | ||
Proceeds from exercise of stock options | 2 | 16 | |
Repurchase of shares for minimum tax withholdings | (3) | (78) | |
Net cash provided by financing activities | 87 | 120,806 | |
Effect of exchange rate changes on cash and cash equivalents | (90) | (137) | |
Increase in cash and cash equivalents | 18,088 | 11,132 | |
Cash and cash equivalents beginning of period | 34,012 | 22,880 | |
Cash and cash equivalents end of period | 52,100 | 34,012 | |
Supplemental disclosure of cash flow information: | |||
Cash paid for interest | $ 1,614 | $ 1,969 | |
[1] As discussed in Note 7. Debt Facility , 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. |
Description of Business and Bas
Description of Business and Basis of Presentation | 12 Months Ended |
Dec. 31, 2022 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Description of Business and Basis of Presentation | 1. Description of Business and Basis of Presentation Description of Business Savara Inc. (together with its subsidiaries “Savara,” the “Company,” “we,” "our" or “us”) is a clinical-stage biopharmaceutical company focused on rare respiratory diseases. The Company’s lead program, molgramostim nebulizer solution (“molgramostim”), is an inhaled granulocyte-macrophage colony-stimulating factor in Phase 3 development for autoimmune pulmonary alveolar proteinosis (“aPAP”). Previously, the Company’s pipeline included molgramostim for nontuberculous mycobacterial (NTM) lung infection in both non-cystic fibrosis (“CF”) and CF patients, vancomycin hydrochloride inhalation powder (“vancomycin”) for persistent methicillin-resistant Staphylococcus aureus (“MRSA”) lung infection in people living with CF and inhaled liposomal ciprofloxacin (“Apulmiq”) for non-CF bronchiectasis. The Company and its wholly-owned subsidiaries operate in one segment with its principal office in Austin, Texas as of December 31, 2022, though a significant portion of our employees work remotely. Since inception, Savara has devoted substantially all of its efforts and resources to identifying and developing its product candidates, recruiting personnel, and raising capital. Savara has incurred operating losses and negative cash flow from operations and has no product revenue from inception to date. The Company has not yet commenced commercial operations. Basis of Presentation The consolidated financial statements have been prepared in conformity with accounting principles generally accepted in the United States (“U.S. GAAP”) as defined by the Financial Accounting Standards Board (the “FASB”). Certain prior year amounts have been reclassified for consistency with the current period presentation. |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 12 Months Ended |
Dec. 31, 2022 | |
Accounting Policies [Abstract] | |
Summary of Significant Accounting Policies | 2. Summary of Significant Accounting Policies Principles of Consolidation The consolidated financial statements of the Company are stated in U.S. dollars. These financial statements include the accounts of the Company and its wholly-owned subsidiaries. The financial statements of the Company’s wholly-owned subsidiaries are recorded in their functional currency and translated into the reporting currency. The cumulative effect of changes in exchange rates between the foreign entity’s functional currency and the reporting currency is reported in Accumulated other comprehensive income (loss) . All intercompany transactions and accounts have been eliminated in consolidation. Liquidity As of December 31, 2022, the Company had an accumulated deficit of approximately $ 338.7 million . The Company used cash from operations of approximately $ 34.6 million for the year ended December 31, 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 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 had cash and cash equivalents of $ 52.1 million and short-term investments of $ 73.8 million as of December 31, 2022, which is sufficient to fund the Company's operations for the twelve months subsequent to the issuance date of its consolidated financial statements for the year ended December 31, 2022. 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 may need to reevaluate its long-term operating plans. The consolidated financial statements do not include any adjustments that might result from the outcome of this uncertainty. In addition, on March 10, 2023, the FDIC took control of Silicon Valley Bank and created the National Bank of Santa Clara to hold the deposits of Silicon Valley Bank after Silicon Valley Bank was unable to continue its operations. Silicon Valley Bank’s deposits are insured by the FDIC, in amount up to $ 250 thousand for any depositor; any deposit in excess of this insured amount could be lost. The U.S. Department of the Treasury, Federal Reserve Board, and FDIC stated that all depositors of Silicon Valley Bank would have access to all deposits after one business day following the date of closure; we and other depositors with Silicon Valley Bank received such access on March 13, 2023. Additionally, Treasury Secretary Janet L. Yellen, Federal Reserve Chair Jerome H. Powell and FDIC Chairman Martin J. Gruenberg have announced that all bank depositors, including deposits in excess of the FDIC Limit, with SVB will be fully protected. In order to mitigate risks associated with our banking deposits, the Company maintains a significant portion of its liquidity in U.S. Treasury money market funds and other short-term investments with custodial services provided by U.S. Bank, N.A., refer to Note 5. Short-term Investments and Note 8. Fair Value Measurements . The Company continues to monitor the circumstances surrounding Silicon Valley Bank and does not anticipate a material impact on its financial condition or operations based upon the FDIC’s management of Silicon Valley Bank’s assets and operations; however, it continues to monitor the situation. Use of Estimates The preparation of financial statements in conformity with U.S. GAAP requires the Company to make certain estimates and assumptions that affect the amounts reported in the financial statements and accompanying notes. Management’s estimates include those related to the accrual of research and development and general and administrative costs, certain financial instruments recorded at fair value, stock-based compensation, and the valuation allowance for deferred tax assets. The Company bases its estimates on historical experience and on various other market-specific and relevant assumptions that it believes to be reasonable under the circumstances. Accordingly, actual results could be materially different from those estimates. Risks and Uncertainties The product candidate being developed by the Company require approval from the U.S. Food and Drug Administration (the “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 will have a material adverse impact on the Company’s business, results of operations, and financial position. The Company is subject to a number of risks similar to other life science companies, including, but not limited to, risks related to the successful discovery and development of drug candidates, raising additional capital, development of competing drugs and therapies, protection of proprietary technology, and market acceptance of the Company’s products. As a result of these and other factors and the related uncertainties, there can be no assurance of the Company’s future success. Cash and Cash Equivalents Cash and cash equivalents consist of cash and institutional bank money market accounts with original maturities of three months or less when acquired and are stated at cost, which approximates fair value. Short-term Investments The Company has classified its investments in debt securities with readily determinable fair value as available-for-sale securities. These securities are carried at estimated fair value with the aggregate unrealized gains and losses related to these investments reflected as a part of Accumulated other comprehensive income (loss) within stockholders’ equity. The fair value of the investments is based on the specific quoted market price of the securities or comparable securities at the balance sheet dates. Investments in debt securities are considered to be impaired when a decline in fair value is judged to be other than temporary because the Company either intends to sell or it is more-likely-than not that it will have to sell the impaired security before recovery. Once a decline in fair value is determined to be other than temporary, an impairment charge is recorded and a new cost basis in the investment is established. Refer to Note 5. Short-term Investments for additional discussion. Concentration of Credit Risk We are subject to credit risk from our portfolio of cash equivalents and marketable securities. These investments were made in accordance with our investment policy which specifies the categories, allocations, and ratings of securities we may consider for investment. The primary objective of our investment activities is to preserve principal while at the same time maximizing the income we receive without significantly increasing risk. We maintain our cash and cash equivalents and marketable securities with a limited number of financial institutions. Deposits held with the financial institutions exceed the amount of insurance provided on such deposits. We are exposed to credit risk in the event of a default by the financial institutions holding our cash, cash equivalents and marketable securities to the extent recorded on the consolidated balance sheets. Accrued Research and Development Costs The Company records the costs associated with research, nonclinical and clinical trials, and manufacturing development as incurred. These costs are a significant component of the Company’s research and development expenses, with a substantial portion of the Company’s on-going research and development activities conducted by third party service providers, including contract research and manufacturing organizations. The Company accrues for expenses resulting from obligations under agreements with contract research organizations (“CROs”), contract manufacturing organizations (“CMOs”), and other outside service providers for which payment flows do not match the periods over which materials or services are provided to the Company. Accruals are recorded based on estimates of services received and efforts expended pursuant to agreements established with CROs, CMOs, and other outside service providers. These estimates are typically based on contracted amounts applied to the proportion of work performed and determined through analysis with internal personnel and external service providers as to the progress or stage of completion of the services. The Company makes significant judgments and estimates in determining the accrual balance in each reporting period. In the event advance payments are made to a CRO, CMO, or outside service provider, the payments will be recorded as a prepaid asset which will be amortized or expensed as the contracted services are performed. As actual costs become known, the Company adjusts its prepaids and accruals. Inputs, such as the services performed, the number of patients enrolled, or the trial duration, may vary from the Company’s estimates, resulting in adjustments to research and development expense in future periods. Changes in these estimates that result in material changes to the Company’s accruals could materially affect the Company’s results of operations. To date, the Company has not experienced any material deviations between accrued and actual research and development expenses. Refer to Note 4. Accrued Expenses and Other Current Liabilities for additional discussion. Business Combinations The Company accounts for business combinations in accordance with Accounting Standards Codification (“ASC”) Topic 805, Business Combinations , and as further defined by Accounting Standards Update (“ASU”) 2017-01, Business Combinations (Topic 805) , which requires the purchase price to be measured at fair value. When the purchase consideration consists entirely of shares of our common stock, the Company calculates the purchase price by determining the fair value, as of the acquisition date, of shares issued in connection with the closing of the acquisition and, if the transaction involves contingent consideration based on achievement of milestones or earn-out events, the probability-weighted fair value, as of the acquisition date, of shares issuable upon the occurrence of future events or conditions pursuant to the terms of the agreement governing the business combination. If the transaction involves such contingent consideration, our calculation of the purchase price involves probability inputs that are highly judgmental due to the inherent unpredictability of drug development, particularly by development-stage companies. The Company recognizes estimated fair values of the tangible assets and intangible assets acquired, including in process research and development (“IPR&D”), and liabilities assumed as of the acquisition date, and we record as goodwill any amount of the purchase price of the tangible and intangible assets acquired and liabilities assumed in excess of the fair value. License and Collaboration Agreements From time to time the Company enters and may continue to enter into license and collaboration agreements with third parties whereby the Company purchases the rights to develop, market, sell and/or distribute the underlying pharmaceutical products or drug candidates. Pursuant to these agreements, the Company may be required to make up-front payments, milestone payments contingent upon the achievement of certain pre-determined criteria, royalty payments based on specified sales levels of the underlying products, and/or certain other payments. Up-front payments are either expensed immediately as research and development or capitalized. The determination to capitalize amounts related to licenses is based on management’s judgments with respect to stage of development, the nature of the rights acquired, alternative future uses, developmental and regulatory issues and challenges, the net realizable value of such amounts based on projected sales of the underlying products, the commercial status of the unde rlying products, and/or various other competitive factors. Milestone payments made prior to regulatory approval are generally expensed as incurred and milestone payments made subsequent to regulatory approval are generally capitalized as an intangible asset. Royalty payments are expensed as incurred. Other payments made pursuant to license and collaboration agreements, which are generally related to research and development activities, are expensed as incurred. Goodwill and Acquired In-Process Research and Development In accordance with ASC Topic 350, Intangibles – Goodwill and Other , the Company's acquired IPR&D and goodwill, when applicable, is determined to have indefinite lives and, therefore, is not amortized. Instead, it is tested for impairment annually and between annual tests if the Company becomes aware of an event or a change in circumstances that would indicate the carrying value may be impaired. For instance, based upon the ultimate scope and scale of the COVID-19 global pandemic, there may be materially negative impacts to the assumptions made with respect to our IPR&D assets that could result in an impairment of such assets. With respect to the impairment testing of acquired IPR&D, ASU 2011-08, Intangibles – Goodwill and Other (Topic 350): Testing Goodwill for Impairment , and ASU 2012-02, Intangibles – Goodwill and Other (Topic 350): Testing Indefinite-Lived Intangible Assets for Impairment , provides for a two-step impairment process with the option to first assess qualitative factors to determine whether the existence of events or circumstances leads to the determination that it is more-likely-than not (that is, a likelihood of more than 50%) that acquired IPR&D is impaired. If the Company chooses to first assess qualitative factors and it determines that it is more-likely-than not acquired IPR&D is not impaired, the Company is not required to take further action to test for impairment. ASU 2017-04, Intangibles – Goodwill and Other (Topic 350): Simplifying the Test for Goodwill Impairment , outlines an impairment model providing us the option to implement a one-step method for determining impairment of goodwill, thereby simplifying the subsequent measurement of goodwill by eliminating Step 2 (quantitative calculation of measuring a goodwill impairment loss by comparing the implied fair value of a reporting unit’s goodwill with the carrying amount of that goodwill) from the goodwill impairment test. Under the amendments in this guidance, an entity should perform its annual or interim goodwill impairment test by comparing the fair value of a reporting unit with its carrying amount. An entity should recognize an impairment charge for the amount by which the carrying amount exceeds the reporting unit’s fair value; however, the loss recognized should not exceed the total amount of goodwill allocated to that reporting unit. Additionally, an entity should consider income tax effects from any tax-deductible goodwill on the carrying amount of the reporting unit when measuring the goodwill impairment loss, if applicable. When the Company performs a quantitative assessment of acquired IPR&D, it compares its carrying value to its estimated fair value to determine whether an impairment exists. Due to a lack of Level 1 or Level 2 inputs, the Multi-Period Excess Earnings Method (“MPEEM”), which is a form of the income approach, was used to estimate the fair value of acquired IPR&D when performing a quantitative assessment. Under the MPEEM, the fair value of an intangible asset is equal to the present value of the asset’s projected incremental after-tax cash flows (excess earnings) remaining after deducting the market rates of return on the estimated value of contributory assets (contributory charge) over its remaining useful life. The Company evaluates potential impairment of its acquired IPR&D annually on September 30, utilizing a qualitative approach and determining if it was more-likely-than not that the fair value was impaired. We evaluate potential impairment of our acquired goodwill, if any, annually on or around June 30, performing the quantitative analysis based upon market capitalization. Our determinations as to whether, and if so, the extent to which goodwill and acquired IPR&D become impaired are highly judgmental and, in the case of applying the MPEEM approach to estimate fair value, are based on significant assumptions regarding our projected future financial condition and operating results, changes in the manner of our use of the acquired assets, development of our acquired assets or our overall business strategy, and regulatory, market, and economic environment and trends . If the associated research and development effort is abandoned, the related asset will be written-off, and the Company will record a non-cash impairment loss on its consolidated statements of operations and comprehensive loss. For those products that reach commercialization, the IPR&D asset will be amortized over its estimated useful life. Refer to Note 8. Fair Value Measurements – Assets and Liabilities Measured at Fair Value on a Nonrecurring Basis for additional discussion. Leases The Company accounts for a contract as a lease when it has the right to control the asset for a period of time while obtaining substantially all of the asset's economic benefits in accordance with ASU 2016-02, Leases (Topic 842), as codified in ASC 842, Leases . Lease right-of-use assets and liabilities are initially recorded on the lease commencement date based on the present value of lease payments over the lease term. The present value of lease payments is determined by using the interest rate implicit in the lease, if that rate is readily determinable; otherwise, the Company uses its estimated secured incremental borrowing rate for that lease term. Leases may include renewal, purchase or termination options that can extend or shorten the term of the lease. The exercise of those options is at the Company's sole discretion and is evaluated at inception and throughout the contract to determine if a modification of the lease term is required. In addition to rent, the leases may require the Company to pay additional amounts for taxes, insurance, maintenance, and other expenses, which are generally referred to as non-lease components. The Company has elected to not separate lease and non-lease components. Only the fixed costs for lease components and their associated non-lease components are accounted for as a single lease component and recognized as part of a right-of-use asset and liability. Rent expense is recognized on a straight-line basis over the reasonably assured lease term based on the total lease payments and is included in operating expenses in the consolidated statements of operations and comprehensive loss. The Company has made an accounting policy election providing that leases with an initial term of 12 months or less are not recorded as a lease right-of-use asset and corresponding liability in accordance with ASC 842, Leases ; those lease payments are recognized in the consolidated statements of operations and comprehensive loss on a straight-line basis over the lease term. Refer to Note 10. Commitments – Operating Leases for additional discussion. Segment Reporting Operating segments are identified as components of an enterprise about which separate discrete financial information is available for evaluation by the chief operating decision maker, or decision making group, in making decisions on how to allocate resources and assess performance. Our chief operating decision maker is the chief executive officer. We have one operating segment, specialty pharmaceuticals within the respiratory system. Property and Equipment Property and equipment are stated at cost, net of accumulated depreciation. Depreciation is determined on a straight-line basis over the estimated useful lives of the assets, which range from three to five years . Repairs and maintenance that do not improve or extend the useful life of the respective asset are charged to expense as incurred. Refer to Note 6. Property and Equipment, net for additional discussion. Patents and Intellectual Property As the Company’s products are currently under research and development and are not currently approved for market, costs incurred in connection with patent applications are expensed as incurred due to the uncertainty of the future economic benefits of the underlying patents and intellectual property. Fair Value of Financial Instruments The accounting standard for fair value measurements provides a framework for measuring fair value and requires disclosures regarding fair value measurements. Fair value is defined as the price that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date, based on the Company’s principal or, in absence of a principal, most advantageous market for the specific asset or liability. The Company uses a three-tier fair value hierarchy to classify and disclose all assets and liabilities measured at fair value on a recurring basis, as well as assets and liabilities measured at fair value on a non-recurring basis, in periods subsequent to their initial measurement. The hierarchy requires the Company to use observable inputs when available, and to minimize the use of unobservable inputs, when determining fair value. The three tiers are defined as follows: • Level 1 – Observable inputs that reflect quoted market prices (unadjusted) for identical assets or liabilities in active markets; • Level 2 – Observable inputs other than quoted prices in active markets that are observable either directly or indirectly in the marketplace for identical or similar assets and liabilities; and • Level 3 – Unobservable inputs that are supported by little or no market data, which require the Company to develop its own assumptions. Financial instruments carried at fair value include cash and cash equivalents, short-term investments, and foreign exchange derivatives not designated as hedging instruments. Financial instruments not carried at fair value include accounts payable and accrued liabilities. The carrying amounts of these financial instruments approximate fair value due to the highly liquid nature of these short-term instruments. Refer to Note 8. Fair Value Measurements for additional discussion. Revenue Recognition The Company records revenue based on a five-step model in accordance with ASC 606, Revenue from Contracts with Customers . To date, the Company has not generated any product revenue. The Company’s ability to generate product revenues, which the Company does not expect will occur in the next several years, if ever, will depend heavily on the successful development, regulatory approval, and eventual commercialization of the Company’s product candidates. Net Loss per Share Basic net loss attributable to common stockholders per share is calculated by dividing the net loss attributable to common stockholders by the weighted average number of shares of common stock and pre-funded warrants outstanding during the period without consideration of common stock equivalents. Since the Company was in a loss position for all periods presented, diluted net loss per share is the same as basic net loss per share for all periods presented as the inclusion of all potential dilutive securities would have been antidilutive. Refer to Note 14. Net Loss per Share for additional discussion. Stock-Based Compensation The Company recognizes the cost of stock-based awards granted to employees based on the estimated grant-date fair value of the awards. The value of the portion of the award is recognized as expense ratably over the requisite service period. The Company recognizes the compensation costs for awards that vest over several years on a straight-line basis over the vesting period. Forfeitures are recognized when they occur, which may result in the reversal of compensation costs in subsequent periods as the forfeitures arise. In addition, the Company accounts for any modifications to stock-based awards in accordance with ASC Topic 718, Compensation – Stock Compensation . Refer to Note 12. Stock-Based Compensation for additional discussion. Income Taxes The Company uses the asset and liability method of accounting for income taxes. Under this method, deferred tax assets and liabilities are recognized for the expected future tax consequences of temporary differences between the carrying amounts and the tax basis of assets and liabilities. Deferred tax assets and liabilities are measured using enacted tax rates expected to apply to taxable income in the years in which those temporary differences are expected to be recovered or settled. The effect of a change in tax rates on deferred tax assets and liabilities will be recognized in the period that includes the enactment date. A valuation allowance is established against the deferred tax assets to reduce their carrying value to an amount that is more-likely-than not to be realized. Refer to Note 13. Income Taxes for additional discussion. 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 consolidated financial statements. |
Prepaid Expenses and Other Curr
Prepaid Expenses and Other Current Assets | 12 Months Ended |
Dec. 31, 2022 | |
Prepaid Expense and Other Assets, Current [Abstract] | |
Prepaid Expenses and Other Current Assets | 3. Prepaid Expenses and Other Current Asset s Prepaid expenses, consisted of (in thousands): December 31, 2022 2021 Prepaid contracted research and development costs $ 1,822 $ 1,902 R&D tax credit receivable 792 838 VAT receivable 162 306 Prepaid insurance 231 427 Deposits and other 71 356 Total prepaid expenses and other current assets $ 3,078 $ 3,829 Prepaid Contracted Research and Development Costs As of December 31, 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 CROs, CMOs, and other outside service providers that provide services in connection with the Company's research and development activities. Tax Credit Receivable The Company has recorded a Danish tax credit earned by its subsidiary, Savara ApS, as of December 31, 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 $ 0.8 million which was received in the fourth quarter of 2022. During the year ended December 31, 2022 , the Company generated a Danish tax credit of $ 0.8 million which is expected to be received in the fourth quarter of 2023. |
Accrued Expenses and Other Curr
Accrued Expenses and Other Current Liabilities | 12 Months Ended |
Dec. 31, 2022 | |
Payables and Accruals [Abstract] | |
Accrued Expenses and Other Current Liabilities | 4. Accrued Expenses and Other Current Liabilities Accrued expenses and other liabilities, consisted of (in thousands): December 31, 2022 2021 Accrued compensation $ 2,365 $ 2,526 Accrued contracted research and development costs 1,322 1,623 Accrued general and administrative costs 782 600 Lease liability 64 135 Total accrued expenses and other current liabilities $ 4,533 $ 4,884 Accrued Compensation As of December 31, 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 amount accrued for such compensation may vary due to many factors including, but not limited to, timing of payments to employees and vacation usage. Accrued Contracted Research and Development Costs As of December 31, 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. |
Short-term Investments
Short-term Investments | 12 Months Ended |
Dec. 31, 2022 | |
Investments, Debt and Equity Securities [Abstract] | |
Short-term Investments | 5. Short-term Investments Short-term Investments in Available-for-Sale Securities The Company’s investment policy seeks to preserve capital and maintain sufficient liquidity to meet operational and other needs of the business. The following table summarizes, by major security type, the Company’s investments (in thousands): As of December 31, 2022 Amortized Cost Gross Unrealized Gains Gross Unrealized Losses Fair Value Short-term investments U.S. government securities $ 73,784 $ 8 $ ( 16 ) $ 73,776 Asset backed securities — — — — Corporate securities — — — — Commercial paper — — — — Total short-term investments (*) $ 73,784 $ 8 $ ( 16 ) $ 73,776 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 * Designated custodial institution, U.S. Bank, N.A. The Company has classified its investments as available-for-sale securities. These securities are carried at estimated fair value with the aggregate unrealized gains and losses related to these investments reflected as a part of Accumulated other comprehensive income (loss) in the consolidated balance sheet. Classification as short-term or long-term is based upon whether the maturity of the debt securities is less than or greater than twelve months. There were no significant realized gains or losses related to investments for the years ended December 31, 2022 and 2021 . |
Property and Equipment, Net
Property and Equipment, Net | 12 Months Ended |
Dec. 31, 2022 | |
Property, Plant and Equipment [Abstract] | |
Property and Equipment, Net | 6. Property and Equipment, Net Property and equipment, net consisted of (in thousands): December 31, 2022 2021 Research and development equipment $ 1,102 $ 1,102 Equipment 666 746 Furniture and fixtures 61 151 Leasehold improvements 145 153 Total property and equipment 1,974 2,152 Less accumulated depreciation ( 1,923 ) ( 2,079 ) Property and equipment, net $ 51 $ 73 Depreciation expense for the years ended December 31, 2022 and 2021 was minimal, respectively. |
Debt Facility
Debt Facility | 12 Months Ended |
Dec. 31, 2022 | |
Debt Disclosure [Abstract] | |
Debt Facility | 7. Debt Facility 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 consolidated statement of operations. On March 10, 2023, the FDIC took control and was appointed receiver of Silicon Valley Bank. As such, the Company is monitoring the impact on the Amended Loan Agreement. 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, 2023 $ — 2024 — 2025 — 2026 17,667 2027 9,562 Total future minimum payments 27,229 Unamortized end of term charge ( 630 ) Debt issuance costs ( 478 ) Debt discount related to warrants ( 43 ) Total debt 26,078 Current portion of long-term debt — Long-term debt $ 26,078 |
Fair Value Measurements
Fair Value Measurements | 12 Months Ended |
Dec. 31, 2022 | |
Fair Value Disclosures [Abstract] | |
Fair Value Measurements | 8 . Fair Value Measurements The Company measures and reports certain financial instruments at fair value on a recurring basis and evaluates its financial instruments subject to fair value measurements on a recurring and nonrecurring basis to determine the appropriate level in which to classify them in each reporting period. 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 December 31, 2022 and 2021 was as follows (in thousands): Quoted Prices in Significant Significant Total As of December 31, 2022 Cash equivalents (*): U.S. Treasury money market funds $ 48,804 $ — $ — $ 48,804 Short-term investments (*): U.S. government securities 73,776 — — 73,776 Asset backed securities — — — — Corporate securities — — — — Commercial paper — — — — 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 * Designated custodial institution, U.S. Bank, N.A. The Company did no t transfer any assets measured at fair value on a recurring basis to or from Level 1, Level 2, and Level 3 during the years ended December 31, 2022 and 2021. Assets and Li abilities 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 IPR&D and other long-lived assets that are written down to fair value if they are impaired. As of December 31, 2022, the Company had IPR&D of approximately $ 10.7 million . At December 31, 2022, the Company performed an impairment analysis and concluded that the impact of COVID-19 or other factors did not trigger any impairment indicators. For the years ended December 31, 2022 and 2021, the Company experienced a decrease of approximately $ 0.6 million and a decrease of approximately $ 0.9 million, respectively, in the carrying value of IPR&D, which was due to foreign currency translation. |
Stockholders_ Equity
Stockholders’ Equity | 12 Months Ended |
Dec. 31, 2022 | |
Equity [Abstract] | |
Stockholders’ Equity | 9. Stockh olders’ Equity Private Placement On December 24, 2019, the Company completed a private placement in a public entity (the “Private Placement” or “PIPE”) under a Securities Purchase Agreement (the “Purchase Agreement”) with certain institutional and accredited investors (the “Investors”), pursuant to which we issued and sold to the Investors 9,569,430 shares of our common stock at a price of $ 1.745 per share and pre-funded warrants (“Pre-Funded PIPE Warrants”) to purchase an aggregate of 5,780,537 shares of common stock at $ 1.744 per share (or $ 1.745 minus the exercise price of $ .001 ). The net proceeds after deducting placement fees and offering expenses were approximately $ 25.2 million. We also issued accompanying warrants (the “Milestone Warrants”), with an exercise price of $ 1.48 per share, to purchase an aggregate of up to 32,577,209 additional shares of common stock and may receive up to approximately $ 48.2 million from the exercise of the Milestone Warrants prior to their expiration, totaling potential aggregate gross proceeds of up to approximately $ 75.0 million from the PIPE before deducting placement agent fees and estimated offering expenses. The Milestone Warrants were exercisable at any time prior to the earlier of thirty days following the achievement of a defined clinical milestone or two years after the closing date of the Private Placement. The Pre-Funded PIPE Warrants are exercisable at any time after their original issuance and will not expire. We intend to use the net proceeds from the Private Placement to fund a new clinical trial of molgramostim for the treatment of aPAP and for other general corporate purposes. The net proceeds from the Private Placement were allocated among the instruments based upon their relative fair values at December 24, 2019 resulting in carry values of the respective instruments as follows (in thousands): Financial instruments Relative Fair Value Common stock and Pre-Funded PIPE Warrants $ 11,713 Milestone Warrants 13,534 Total Net Proceeds from Private Placement $ 25,247 Milestone Warrants Immediately prior to the March 15, 2021 Public Offering, discussed below, the Company entered into separate, privately-negotiated warrant repurchase agreements with certain holders of its outstanding Milestone Warrants. 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 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 expired and therefore such Milestone Warrants were terminated and no longer outstanding or exercisable . Public Offering of Common Stock On March 15, 2021, the Company sold (i) an aggregate of 57,479,978 shares of the Company’s common stock, par value $ 0.001 per share (the “Common Stock”) for $ 1.45 per share, of which 11,694,150 shares were issued pursuant to the underwriters’ option to purchase additional shares, and (ii) pre-funded warrants to purchase an aggregate of 32,175,172 shares of Common Stock at an exercise price of $ 0.001 per share (the “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 Liabilities 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 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 amended by Amendment No. 1 to the Common Stock Agreement (the “Amendment”) on June 29, 2018 (the “Wainwright Sales Agreement”), pursuant to which the Company may offer and sell, from time to time, through Wainwright, shares of Savara’s common stock, par value $ 0.001 per share (the “Shares”), 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 Amendment was effective on July 13, 2018, the date the Company’s shelf registration statement on Form S-3, as filed with the Securities and Exchange Commission on June 29, 2018, was declared effective (“2018 Registration Statement”) by the Securities and Exchange Commission. The Shares were offered and sold pursuant to the 2018 Registration Statement. Subject to the terms and conditions of the Wainwright Sales Agreement, Wainwright used its commercially reasonable efforts to sell the Shares from time to time, based upon the Company’s instructions. The Company has provided Wainwright with customary indemnification rights, and Wainwright was entitled to a commission at a fixed commission rate equal to 3.0 % of the gross proceeds per Share sold. Sales of the Shares, if any, under the Wainwright 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 Wainwright Sales Agreement or terminate the Wainwright Sales Agreement . On July 2, 2021, the Company delivered written notice to Wainwright that it was terminating the Wainwright Sales Agreement effective July 12, 2021 . 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 “Sales Agreement”), pursuant to which the Company may offer and sell, from time to time, through Evercore, shares of Savara’s common stock, par value $ 0.001 per share (the “Shares”), having an aggregate offering price of not more than $ 60 million. The Agreement was effective on July 16, 2021 (the “New Registration Statement”), the date the Company’s shelf registration agreement on Form S-3, as filed with the SEC on July 6, 2021, 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 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 Sales Agreement may be made in transactions that are deemed to be “at the market offerings” as defined in Rule 415 under the Securities Act of 1933, as amended. The Company has no obligation to sell any of the Shares and may at any time suspend sales under the Sales Agreement or terminate the Sales Agreement. During the year ended December 31, 2022, the Company did no t sell any shares of common stock under the Evercore Sales Agreement. Common Stock The Company’s amended and restated certificate of incorporation, as amended in June 2021, authorizes the Company to issue 301 million shares of capital stock, consisting of 300 million shares of common stock with $ 0.001 par value per share and one million shares of preferred stock with $ 0.001 par value per share. The following is a summary of the Company’s common stock at December 31, 2022 and 2021: December 31 2022 2021 Common stock authorized 300,000,000 300,000,000 Common stock outstanding 114,046,345 114,036,892 The Company’s shares of common stock reserved for issuance as of December 31, 2022 and 2021 were as follows: December 31, 2022 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 7,933,184 6,218,841 Issued and non-vested RSUs 1,942,250 1,272,375 Total shares reserved 48,683,936 46,299,718 Warrants The following table summarizes the outstanding warrants for the Company’s common stock as of December 31, 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 ( 648 ) 38 ( 610 ) Balance, December 31, 2022 $ ( 594 ) $ ( 11 ) $ ( 605 ) |
Commitments
Commitments | 12 Months Ended |
Dec. 31, 2022 | |
Commitments and Contingencies Disclosure [Abstract] | |
Commitments | 10. Comm itments Operating Leases The Company has entered into operating leases for real estate in multiple locations. The Company’s leases have lease terms that include options to extend (in some cases, for up to 36 months ). The exercise of lease renewal and termination options are at the Company’s sole discretion with the exception of the Austin Texas lease, as amended, noted below. For purposes of calculating operating lease liabilities, the Company’s leases are deemed not to include an option to extend the lease term until it is reasonably certain that the Company will exercise that option. The Company has operating lease agreements with lease and non-lease components that are accounted for as a single lease component. The Company previously subleased office space pursuant to a sublease that expired at the end of July 2021 . On June 3, 2021 , the Company entered into a lease agreement (the “Antecedent TX Lease”) with the same landlord for a different office suite located in the same building and relocated its headquarters to this location. The Antecedent TX Lease commencement date was August 1, 2021 and continued through December 31, 2022 . On commencement of the Antecedent TX Lease, the Company recorded an operating lease liability and corresponding right-of-use asset of approximately $ 0.1 million. In December 2022, contemporaneously with the expiration of the Antecedent TX Lease, the Company entered into another lease (the "Current TX Lease") with the same landlord for a different office suite located in the same commercial complex and relocated its headquarters to this location. The term for the Current TX Lease is initially six months or June 30, 2023, at which point it converts to a month-to-month arrangement thereafter with termination rights upon thirty days written notice. Due to the duration of the Current Texas Lease term, no right-of-use asset or corresponding liability has been recorded in accordance with the Company's election under ASC 842 further described in Note 2. Summary of Significant Accounting Policies . On July 7, 2021, the Company entered into a lease agreement (the “PA Lease”) for an office space in Langhorne, Pennsylvania. The PA Lease commencement date was October 1, 2021 and will continue through September 30, 2024 . On commencement of the PA Lease, the Company recorded an operating lease liability and corresponding right-of-use asset of approximately $ 0.2 million. The Company also terminated a lease agreement during the fourth quarter of 2021 . As a result of the termination, the Company paid a fee of approximately $ 20,000 that would have otherwise been payable as part of the property's annual base rent. This termination resulted in a reduction of right-of-use operating lease assets and operating lease liabilities of approximately $ 0.1 million. The following is a maturity analysis of the annual undiscounted cash flows reconciled to the carrying value of the operating lease liabilities as of December 31, 2022 (in thousands): Year ending December 31, 2023 $ 63 2024 54 Total future minimum lease payments $ 117 Less imputed interest ( 7 ) Total $ 110 Operating cash flows from operating leases $ 151 Weighted-average remaining lease term (in months) - operating leases 21.0 Weighted-average discount rate - operating leases 7.8 % As of December 31, 2022, the carrying value of the right-of-use ass ets for the operating leases was $ 0.1 million, which is reflected in Other non-current assets , and the carrying value of the lease liabilities for operating leases was $ 0.1 million, of which approximately $ 0.06 million related to the current portion of the lease liabilities is recorded in Accrued expenses and other current liabilities , and $ 0.05 million related to the non-curr ent portion of the lease liabilities is recorded in Other long-term liabilities . Manufacturing and Other Commitments and Contingencies The Company is subject to various royalties and manufacturing and development payments related to its product candidate, molgramostim. Under a manufacture and supply agreement with the active pharmaceutical ingredients (“API”) manufacturer for molgramostim, Savara must make certain payments to the API manufacturer upon achievement of the milestones outlined in the table set forth below. Additionally, upon first receipt of marketing approval by Savara from a regulatory authority in a country for a product containing the API for therapeutic use in humans and ending the earlier of (i) ten (10) years thereafter or (ii) the date a biosimilar of such product is first sold in such country, Savara shall pay the API manufacturer a royalty equal to low-single digits of the net sales in that country. The Company is also subject to certain contingent milestone payments, disclosed in the following table, payable to the manufacturer of the nebulizer used to administer molgramostim. The change in the amount of the milestone payments from December 31, 2021 to December 31, 2022 was related to foreign currency translation fluctuations. 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. Manufacturing, Development, and Other Contingent Milestone Payments (in thousands): December 31, 2022 Molgramostim manufacturer: Achievement of certain milestones related to validation of API and regulatory approval of $ 2,300 Molgramostim nebulizer manufacturer: Achievement of various development activities and regulatory approval of nebulizer utilized 536 Total manufacturing and other commitments $ 2,836 The milestone commitments disclosed above reflect the activities that have (i) not been met or incurred; (ii) not been remunerated; and (iii) not accrued, as the activities are not deemed probable or reasonably estimable, as of December 31, 2022. On December 10, 2020, the Company announced that the Phase 3 trial of vancomycin in people living with cystic fibrosis who have MRSA lung infection did not meet the primary endpoint. On January 7, 2021 the Company issued a termination notice to GlaxoSmithKline Trading Services Limited (“GSK”), which manufactures the drug product from bulk vancomycin powder. On January 26, 2021, the Company and GSK entered a change order for termination costs associated with the closeout and wind-down of vancomycin activities. During the year ended December 31, 2021, the Company paid approximately $ 0.8 million of research and development expense related to the termination of the manufacturing agreement. Contract Research On March 5, 2021, the Company entered into a Master Services Agreement (“MSA”) with Parexel International (IRL) Limited (“Parexel”) pursuant to which Parexel will provide contract research services related to clinical trials. Contemporaneously with entering the MSA, a wor k order was executed with Parexel, under which they will provide services related to the IMPALA-2 trial. Under that work order and subsequent change orders, the Company will pay Parexel service fees and pass-through expenses estimated to be approximately $ 33.6 million over the course of the IMPALA-2 clinical trial. Risk Management The Company maintains various forms of insurance that the Company's management believes are adequate to reduce the exposure to these risks to an acceptable level. Employment Agreements On December 8, 2020, the Company entered into an employment agreement with the CEO, as amended and restated on December 13, 2022, whereby the CEO is entitled to payments and benefits upon certain events. Upon (i) termination without cause, (ii) termination due to the CEO’s death or disability, or (iii) the CEO’s resignation for good reason, the CEO is entitled to receive (i) a lump sum payment equal to 18 months of base salary, (ii) a lump sum payment equal to 100 % of his target bonus, (iii) a pro-rated portion of the unpaid target bonus, (iv) reimbursement for continued coverage under medical benefit plans for 18 months or until covered under a separate plan from another employer, and (v) the immediate and full vesting of outstanding non-vested Company equity awards. Additionally, all of the CEO’s outstanding stock options will be exercisable through the earlier of (x) the 18 month anniversary of the termination date or (y) the original expiration date. Upon a termination other than for cause, death or disability or resignation for good reason within three months prior to or 12 months following a change in control, the CEO is entitled to receive (i) a lump sum payment of an amount equal to 24 months of base salary, plus 100% of the unpaid target bonus, plus a pro-rated portion of any unpaid bonus earned during the relevant performance period, (ii) reimbursement for continued coverage under medical benefit plans for 24 months or until covered under a separate plan from another employer, and (iii) the immediate and full vesting of outstanding non-vested Company equity awards. Additionally, all of the CEO’s outstanding stock options will be exercisable through the earlier of (x) the 24-month anniversary of the termination date or (y) the original expiration date. Each of the Company’s Chief Financial Officer (“CFO”) and Chief Medical Officer (“CMO”) is entitled to payments and benefits if the CFO or CMO, respectively, is (i) terminated without cause, (ii) terminated due to the CFO or CMO's death or disability, or (iii) resigns for good reason, which includes (i) a lump sum payment equal to 12 months of base salary and a pro-rated portion of their unpaid bonus, (ii) reimbursement for continued coverage under medical benefit plans for 12 months or until covered under a separate plan from another employer, and (iii) accelerated vesting of outstanding non-vested Company equity awards equal to 12 months. Upon a termination other than for cause, death or disability or resignation for good reason within three months prior to or 12 months following a change in control, the CFO or CMO is entitled to receive (i) a lump sum payment of an amount equal to 18 months of base salary, plus 100% of their target bonus, plus a pro-rated portion of their unpaid target bonus, (ii) a lump sum payment equal to the amount required to continue coverage under medical benefit plans for 18 months, and (iii) the immediate and full vesting of outstanding non-vested options at the time of such termination. |
Related Parties
Related Parties | 12 Months Ended |
Dec. 31, 2022 | |
Related Party Transactions [Abstract] | |
Related Parties | 11. Related Parties As an investor with the right to designate a member of the Company’s board of directors, Bain has significant influence over the Company and is thereby considered a related party. Pursuant to the Public Offering on March 15, 2021 (as further discussed in Note 9. Stockholders' Equity ), Bain acquired 19,517,241 shares of the Company’s common stock and 17,175,172 2021 Pre-Funded Warrants. |
Stock-Based Compensation
Stock-Based Compensation | 12 Months Ended |
Dec. 31, 2022 | |
Share-Based Payment Arrangement [Abstract] | |
Stock-Based Compensation | 12. Stock -Based Compensation A. Equity Incentive Plans 2008 Stock Option Plan The Company adopted the Savara Stock Option Plan (the “2008 Plan”), pursuant to which the Company had reserved shares for issuance to employees, directors, and consultants. The 2008 Plan includes (i) the option grant program providing for both incentive and non-qualified stock options, as defined by the Internal Revenue Code, and (ii) the stock issuance program providing for the issuance of awards that are valued based upon common stock, including restricted stock, dividend equivalents, stock appreciation rights, phantom stock, and performance units. The 2008 Plan also allows eligible persons to purchase shares of common stock at an amount determined by the plan administrator. Upon a participant’s termination, the Company retains the right to repurchase non-vested shares issued in conjunction with the stock issuance program at the fair market value per share as of the date of termination. The Company had previously issued incentive and non-qualified options and restricted stock to employees and non-employees under the 2008 Plan. The terms of the stock options, including the exercise price per share and vesting provisions, were determined by the board of directors. Stock options were granted at exercise prices not less than the estimated fair market value of the Company’s common stock at the date of grant based upon objective and subjective factors including: third-party valuations, preferred stock transactions with third parties, current operating and financial performance, management estimates and future expectations. The Company no longer issues stock-based awards under the 2008 Plan. 2015 Omnibus Incentive Option Plan The Company operates the 2015 Omnibus Incentive Plan (the “2015 Plan”), as amended and restated with approval by our stockholders in June 2018 and amended with approval by our stockholders in May 2020 and June 2022. The 2015 Plan provides for the grant of incentive and non-statutory stock options, as well as share appreciation rights, restricted shares, restricted stock units, performance units, shares and other stock-based awards. Share-based awards are subject to terms and conditions established by our board of directors or the compensation committee of our board of directors. As of December 31, 2022, the number of shares of our common stock available for grant under the 2015 Plan was 1,891,422 shares. Shares of common stock that are subject to awards granted under the 2015 Plan shall be counted against the shares available for issuance under this plan as one share for each share subject to a stock option or stock appreciation right and as 1.34 shares for each share subject to an award other than a stock option or a stock appreciation right such as a restricted stock unit (“RSU”). If any shares of common stock subject to an award granted under any of our stockholder-approved, equity-based incentive plans are forfeited, or an award expires or is settled for cash pursuant to the terms of an award, the shares subject to the award may be used again for awards under the 2015 Plan to the extent of the forfeiture, expiration or cash settlement. The shares of common stock will be added back as one share for every share of common stock if the shares were subject to a stock option or stock appreciation right, and as 1.34 shares for every share of common stock if the shares were subject to an award other than a stock option or stock appreciation right. Under the 2015 Plan, the purchase price of shares of common stock covered by a stock option cannot be less than 100 % of the fair market value of the common stock on the date the stock option is granted. Fair market value of the common stock is generally equal to the closing price for the common stock on the principal securities exchange on which the common stock is traded on the date the stock option is granted (or if there was no closing price on that date, on the last preceding date on which a closing price was reported). Under the 2008 and 2015 Plan, stock option grants typically vest quarterly over four years and expire ten years from the grant date and restricted stock unit grants typically vest quarterly over four years or cliff vest after two years . Inducement Plan The Company has granted equity awards under inducement grants filed in accordance with Nasdaq Listing Rule 5635(c)(4) exclusively to the Company’s CMO as an inducement for the CMO to enter into employment with the Company. 2021 Inducement Equity Incentive Plan The Company adopted the 2021 Inducement Equity Incentive Plan (the “Inducement Plan”) with approval by the Company's board of directors in May 2021. The Inducement Plan provides for the grant of non-statutory stock options, restricted stock, restricted stock units, stock appreciation rights, performance units or performance shares. Each award under the Inducement Plan is intended to qualify as an employment inducement grant in accordance with Nasdaq Listing Rule 5635(c)(4). As of December 31, 2022 , the number of shares of common stock available for grant under the 2021 Plan was 1,197,500 shares. Under the Inducement Plan, stock option grants typically vest quarterly over four years and expire ten years from the grant date and restricted stock unit grants typically cliff vest after two years . B. Stock Options and Restricted Stock Units The Company values stock options using the Black-Scholes-Merton option pricing model, which requires the input of subjective assumptions, including the risk-free interest rate, expected life, expected stock price volatility, and dividend yield. The risk-free interest rate assumption is based upon observed interest rates for constant maturity U.S. Treasury securities consistent with the expected term of the Company’s employee stock options. The expected life represents the period of time the stock options are expected to be outstanding and is based on the simplified method. The Company uses the simplified method due to the lack of sufficient historical exercise data to provide a reasonable basis upon which to otherwise estimate the expected life of the stock options. Expected volatility is based on historical volatilities for publicly traded stock of comparable companies over the estimated expected life of the stock options. The Company assumes no dividend yield because dividends are not expected to be paid in the future, consistent with the Company’s history of not paying dividends. The valuation of stock options is also impacted by the valuation of common stock. Restricted stock units are valued at the closing market price of the Company’s common stock on the date of grant. C. Fair Value Assumptions for 2015 Plan The following table summarizes the assumptions used for estimating the fair value of stock options granted to employees for the years ended December 31, 2022 and 2021: 2022 2021 Risk-free interest rate 2.11 % - 3.94 % 0.77 % - 1.27 % Expected term (years) 6.06 6.06 - 6.07 Expected volatility 88.5 % - 97.44 % 79.7 % - 91.2 % Dividend yield 0 % 0 % D. Stock-Based Award Activity The following tables provide a summary for stock option and RSU activity for the year ended December 31, 2022: Stock Options: Shares Underlying Option Awards Weighted-Average Exercise Price Weighted-Average Remaining Contractual Life Aggregate Intrinsic Value (in 000's) Outstanding at December 31, 2021 6,218,841 $ 2.25 8.59 $ 354 Granted 2,812,000 1.48 6.06 Exercised ( 2,344 ) 0.65 2 Expired/cancelled/forfeited ( 1,095,313 ) 1.51 Outstanding at December 31, 2022 7,933,184 $ 2.08 8.40 $ 1,440 Options exercisable at December 31, 2022 3,330,099 $ 3.01 7.16 $ 676 Vested and expected to vest at December 31, 2022 7,933,184 $ 2.08 8.40 $ 1,440 RSUs: Shares Weighted-Average Grant Date Fair Value Outstanding at December 31, 2021 1,272,375 $ 1.20 Granted 949,000 1.49 Vested ( 8,672 ) 3.35 Expired/cancelled/forfeited ( 270,453 ) 1.30 Outstanding at December 31, 2022 1,942,250 $ 1.32 The weighted-average grant date fair values for the Company’s stock options granted during the years ended December 31, 2022 and 2021 were $ 1.13 per share and $ 0.88 per share, respectively. The total compensation cost related to non-vested stock options not yet recognized as of December 31, 2022 was $ 4.7 million, which will be recognized over a weighted-average period of approximately 3.2 years. The total compensation cost related to unvested RSUs not yet recognized as of December 31, 2022 was $ 1.9 million, which will be recognized over a weighted-average period of 1.7 years. During the years ended December 31, 2022 and 2021 , the Company did no t grant any options to purchase shares of common stock to non-employees. The Company recorded a minimal amount of stock-based compensation expense for options issued to non-employees for the years ended December 31, 2022 and 2021, respectively. E. Stock-Based Compensation Stock-based compensation expense is included in the following line items in the accompanying statements of operations and comprehensive loss for the years ended December 31, 2022 and 2021 (in thousands): Year ended December 31, 2022 2021 Research and development $ 448 $ 1,286 General and administrative 1,593 1,974 Total stock-based compensation $ 2,041 $ 3,260 |
Income Taxes
Income Taxes | 12 Months Ended |
Dec. 31, 2022 | |
Income Tax Disclosure [Abstract] | |
Income Taxes | 13. Inc ome Taxes The components of loss before income taxes for the years ended December 31, 2022 and 2021 are as follows (in thousands): December 31, 2022 2021 Domestic $ ( 29,326 ) $ ( 28,705 ) Foreign ( 8,824 ) ( 14,309 ) Total $ ( 38,150 ) $ ( 43,014 ) The Company did no t record a federal tax benefit or expense for the year ended December 31, 2022 . The Company recorded no state provision for income taxes for the years ended December 31, 2022 and 2021 due to revenues below the minimum tax threshold. The components of the benefit for income taxes are as follows for the years ended December 31, 2022 and 2021 (in thousands): December 31, 2022 2021 Current: Federal $ — $ — State — — Foreign — — Total Current — — Deferred: Federal — — State — — Foreign — — Total Deferred — — Total income tax expense (benefit) $ — $ — A reconciliation of the expected income tax results computed using the federal statutory income tax rate to the Company’s effective income tax rate is as follows for the years ended December 31, 2022 and 2021 (in thousands): December 31, 2022 2021 Income tax benefit computed at federal statutory tax rate $ ( 8,011 ) $ ( 9,033 ) Change in valuation allowance 4,286 ( 12,253 ) Orphan drug & research credits generated ( 1,677 ) ( 1,966 ) Orphan drug & research credit expense disallowance — — Impact of foreign operations ( 16 ) ( 177 ) Sec. 382 Limitation — 25,249 Foreign deferred tax asset - true up 2,021 ( 3,833 ) Imputed interest 1,006 1,253 Permanent differences 2,213 738 Other 178 22 Total $ — $ — Deferred income taxes reflect the net tax effects of temporary differences between the carrying amount of assets and liabilities for financial reporting purposes and the amounts used for income tax purposes. The Company has established a valuation allowance due to uncertainties regarding the realization of deferred tax assets based upon the Company’s lack of earnings history. During the years ended December 31, 2022 and 2021 , the valuation allowance increased by $ 3.1 million and decreased by $ 10.9 million, respectively. During 2021, the valuation allowance decreased by $ 25.2 million due to Internal Revenue Code of 1986 Section 382 ("Section 382") limited net operating loss ("NOL") and credits being removed from financial statements; this decrease was offset by increases of approximately $ 13.2 million due to continuing operations and $ 1.1 million due to foreign translation adjustments, which are recorded in OCI. Significant components of the Company’s deferred tax assets and liabilities are as follows (in thousands): December 31, 2022 2021 Deferred tax liabilities: Prepaid assets $ — $ — Other 329 574 Total deferred tax liabilities 329 574 Deferred tax assets: Net operating loss carryforwards 38,969 36,298 Intangible assets 267 5,380 Amortization 1,165 1,212 Credit carryforwards 5,966 4,351 Section 174 research and development expenses 3,663 — Accrued liabilities & other 1,203 1,107 Total deferred tax assets 51,233 48,348 Subtotal 50,904 47,774 Valuation allowance ( 50,904 ) ( 47,774 ) Net deferred taxes $ — $ — During 2021, the Company completed a Section 382 analysis to determine the amount of losses that are currently available for potential offset against future taxable income. Based on the analysis, it was determined that the utilization of the Company's NOLs and tax credit carryforwards generated in tax periods up to and including December 2019 are substantially limited and may result in the expiration of such carryforwards prior to utilization. In general, an ownership change, as defined by Section 382, results from transactions that increase the ownership of 5 % shareholders in the stock of a corporation by more than 50 percentage points in the aggregate over a three-year period. Since the Company's formation, it has raised capital through public or private issuance of common stock on several occasions which have ultimately resulted in multiple changes in ownership, as defined by Section 382. As a result of these ownership changes, $ 47.4 million of NOLs and $ 15.3 million of research and orphan drug credits have been fully restricted from use and were removed from the ending deferred tax assets and 2021 carryforwards mentioned above. As of December 31, 2022 and 2021, the Company still has $ 52.4 million and $ 50.6 million of federal Section 382 NOLs, respectively, which are included in the federal NOL carryforwards below, that are severely limited in future years. As of December 31, 2022 and 2021 , the Company had foreign NOL carryforwards of approximately $ 81.8 million and $ 71.8 million, respectively, which have an indefinite carryforward period. After taking the Section 382 limitations discussed into account, as of December 31, 2022 and 2021, the Company had NOLs for federal income tax purposes of approximatel y $ 98.6 million and $ 96.0 million, respectively. Federal NOL carryforwards of $ 5.2 million begin to expire in 2037 , with $ 93.4 million not having an expiration date. As of December 31, 2022 and 2021 , the Company had state NOL carryforwards of approximately $ 3.5 million, respectively. The state NOL carryforwards begin to expire in 2038 . As of December 31, 2022 and 2021 , the Company also had available research and orphan drug tax credit carryforwards for federal income tax purposes of approximately $ 5.2 million and $ 3.6 million, respectively. If not utilized, these carryforwards expire at various dates beginning in 2039 . As of December 31, 2022 and 2021 , the Company had state research and development tax credit carryforwards of approximately $ 0.5 m illion and $ 0.6 million, respectively, which will begin to expire in 2034 if not utilized. The Company applies the accounting guidance in ASC 740 Income Taxes related to accounting for uncertainty in income taxes. The Company’s reserves related to taxes are based on a determination of whether, and how much of, a tax benefit taken by the Company in its tax filings or positions is more likely than not to be realized following resolution of any potential contingencies present related to the tax benefit. As of December 31, 2022 and 2021 , the Company had no unrecognized tax benefits. During the years ended December 31, 2022 and 2021 , the Company had no interest and penalties related to income taxes. The Company files income tax returns in the U.S. federal, state, and foreign jurisdictions. As of December 31, 2022 , the statute of limitations for assessment by the Internal Revenue Service (“IRS”) is open for the 2018 and subsequent tax years, although carryforward attributes that were generated for tax years prior to then may still be adjusted upon examination by the IRS if they either have been, or will be, used in a future period. The 2017 and subsequent tax years remain open and subject to examination by the state taxing authorities. The 2018 and subsequent tax years remain open and subject to examination by the foreign taxing authorities. There are currently no federal, state, or foreign income tax audits in progress. |
Net Loss Per Share
Net Loss Per Share | 12 Months Ended |
Dec. 31, 2022 | |
Earnings Per Share [Abstract] | |
Net Loss Per Share | 14. Net L oss per Share Basic net loss per share is computed by dividing the net loss by the weighted-average number of common shares outstanding. Diluted net loss per share is computed similarly to basic net loss per share except the denominator is increased to include the number of additional common shares that would have been outstanding if the potential common shares had been issued and if the additional common shares were dilutive. Diluted net loss per share is the same as basic net loss per common share since the effects of potentially dilutive securities are antidilutive. As of December 31, 2022 and 2021, potentially dilutive securities include: Year ended December 31, 2022 2021 Awards under equity incentive plan 7,933,184 6,218,841 Non-vested restricted shares and restricted stock units 1,942,250 1,272,375 Warrants to purchase common stock 77,793 77,793 Total 9,953,227 7,569,009 The following table calculates basic earnings per share of common stock and diluted earnings per share of common stock for the years ended December 31, 2022 and 2021 (in thousands, except share and per share amounts): Year ended December 31, 2022 2021 Net loss $ ( 38,150 ) $ ( 43,014 ) Net loss attributable to common stockholders $ ( 38,150 ) $ ( 43,014 ) Undistributed earnings and net loss attributable to $ ( 38,150 ) $ ( 43,014 ) Weighted-average common shares outstanding, basic 152,771,817 133,919,145 Basic and diluted EPS $ ( 0.25 ) $ ( 0.32 ) |
Subsequent Events
Subsequent Events | 12 Months Ended |
Dec. 31, 2022 | |
Subsequent Events [Abstract] | |
Subsequent Events | 15. Sub sequent Events Langhorne, PA Lease Amendment On February 28, 2023, the Company entered into its first amendment to the PA Lease ("Amended PA Lease") for an expansion of approximately 3,970 additional square feet for a total of approximately 6,435 square feet of office space in Langhorne, Pennsylvania. The Amended PA Lease commencement date is July 1, 2023 and extends the lease period through June 30, 2026. On the Amended PA Lease commencement date, the Company will reevaluate and record an adjusted operating lease liability and corresponding right-of-use asset. Silicon Valley Bank Receivership On March 10, 2023, the FDIC took control of Silicon Valley Bank and created the National Bank of Santa Clara to hold the deposits of Silicon Valley Bank after Silicon Valley Bank was unable to continue their operations. Silicon Valley Bank’s deposits are insured by the FDIC Limit, in amount up to $ 250 thousand for any depositor and any deposit in excess of this insured amount could be lost. The U.S. Department of the Treasury, Federal Reserve Board, and FDIC stated that all depositors of Silicon Valley Bank would have access to all of their money after one business day following the date of closure; we and other depositors with Silicon Valley Bank received such access on March 13, 2023. In order to mitigate risks associated with our banking deposits, the Company maintains a significant portion of its liquidity in U.S. Treasury money market funds and other short-term investments with custodial services provided by U.S. Bank, N.A., refer to Note 5. Short-term Investments and Note 8. Fair Value Measurements . The Company is also monitoring the impact to its Amended Loan Agreement and continues to monitor the circumstances surrounding Silicon Valley Bank. The Company does not anticipate a material impact on its financial condition or operations based upon the FDIC’s management of Silicon Valley Bank’s assets and operations; however, it continues to monitor the situation. The Company has evaluated subsequent events through the date these financial statements were issued. The Company determined there were no further events that required disclosure or recognition in these financial statements. |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Policies) | 12 Months Ended |
Dec. 31, 2022 | |
Accounting Policies [Abstract] | |
Basis of Presentation | Basis of Presentation The consolidated financial statements have been prepared in conformity with accounting principles generally accepted in the United States (“U.S. GAAP”) as defined by the Financial Accounting Standards Board (the “FASB”). Certain prior year amounts have been reclassified for consistency with the current period presentation. |
Principles of Consolidation | Principles of Consolidation The consolidated financial statements of the Company are stated in U.S. dollars. These financial statements include the accounts of the Company and its wholly-owned subsidiaries. The financial statements of the Company’s wholly-owned subsidiaries are recorded in their functional currency and translated into the reporting currency. The cumulative effect of changes in exchange rates between the foreign entity’s functional currency and the reporting currency is reported in Accumulated other comprehensive income (loss) . All intercompany transactions and accounts have been eliminated in consolidation. |
Liquidity | Liquidity As of December 31, 2022, the Company had an accumulated deficit of approximately $ 338.7 million . The Company used cash from operations of approximately $ 34.6 million for the year ended December 31, 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 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 had cash and cash equivalents of $ 52.1 million and short-term investments of $ 73.8 million as of December 31, 2022, which is sufficient to fund the Company's operations for the twelve months subsequent to the issuance date of its consolidated financial statements for the year ended December 31, 2022. 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 may need to reevaluate its long-term operating plans. The consolidated financial statements do not include any adjustments that might result from the outcome of this uncertainty. In addition, on March 10, 2023, the FDIC took control of Silicon Valley Bank and created the National Bank of Santa Clara to hold the deposits of Silicon Valley Bank after Silicon Valley Bank was unable to continue its operations. Silicon Valley Bank’s deposits are insured by the FDIC, in amount up to $ 250 thousand for any depositor; any deposit in excess of this insured amount could be lost. The U.S. Department of the Treasury, Federal Reserve Board, and FDIC stated that all depositors of Silicon Valley Bank would have access to all deposits after one business day following the date of closure; we and other depositors with Silicon Valley Bank received such access on March 13, 2023. Additionally, Treasury Secretary Janet L. Yellen, Federal Reserve Chair Jerome H. Powell and FDIC Chairman Martin J. Gruenberg have announced that all bank depositors, including deposits in excess of the FDIC Limit, with SVB will be fully protected. In order to mitigate risks associated with our banking deposits, the Company maintains a significant portion of its liquidity in U.S. Treasury money market funds and other short-term investments with custodial services provided by U.S. Bank, N.A., refer to Note 5. Short-term Investments and Note 8. Fair Value Measurements . The Company continues to monitor the circumstances surrounding Silicon Valley Bank and does not anticipate a material impact on its financial condition or operations based upon the FDIC’s management of Silicon Valley Bank’s assets and operations; however, it continues to monitor the situation. |
Use of Estimates | Use of Estimates The preparation of financial statements in conformity with U.S. GAAP requires the Company to make certain estimates and assumptions that affect the amounts reported in the financial statements and accompanying notes. Management’s estimates include those related to the accrual of research and development and general and administrative costs, certain financial instruments recorded at fair value, stock-based compensation, and the valuation allowance for deferred tax assets. The Company bases its estimates on historical experience and on various other market-specific and relevant assumptions that it believes to be reasonable under the circumstances. Accordingly, actual results could be materially different from those estimates. |
Risks and Uncertainties | Risks and Uncertainties The product candidate being developed by the Company require approval from the U.S. Food and Drug Administration (the “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 will have a material adverse impact on the Company’s business, results of operations, and financial position. The Company is subject to a number of risks similar to other life science companies, including, but not limited to, risks related to the successful discovery and development of drug candidates, raising additional capital, development of competing drugs and therapies, protection of proprietary technology, and market acceptance of the Company’s products. As a result of these and other factors and the related uncertainties, there can be no assurance of the Company’s future success. |
Cash and Cash Equivalents | Cash and Cash Equivalents Cash and cash equivalents consist of cash and institutional bank money market accounts with original maturities of three months or less when acquired and are stated at cost, which approximates fair value. |
Short-term Investments | Short-term Investments The Company has classified its investments in debt securities with readily determinable fair value as available-for-sale securities. These securities are carried at estimated fair value with the aggregate unrealized gains and losses related to these investments reflected as a part of Accumulated other comprehensive income (loss) within stockholders’ equity. The fair value of the investments is based on the specific quoted market price of the securities or comparable securities at the balance sheet dates. Investments in debt securities are considered to be impaired when a decline in fair value is judged to be other than temporary because the Company either intends to sell or it is more-likely-than not that it will have to sell the impaired security before recovery. Once a decline in fair value is determined to be other than temporary, an impairment charge is recorded and a new cost basis in the investment is established. Refer to Note 5. Short-term Investments for additional discussion. |
Concentration of Credit Risk | Concentration of Credit Risk We are subject to credit risk from our portfolio of cash equivalents and marketable securities. These investments were made in accordance with our investment policy which specifies the categories, allocations, and ratings of securities we may consider for investment. The primary objective of our investment activities is to preserve principal while at the same time maximizing the income we receive without significantly increasing risk. We maintain our cash and cash equivalents and marketable securities with a limited number of financial institutions. Deposits held with the financial institutions exceed the amount of insurance provided on such deposits. We are exposed to credit risk in the event of a default by the financial institutions holding our cash, cash equivalents and marketable securities to the extent recorded on the consolidated balance sheets. |
Accrued Research and Development Costs | Accrued Research and Development Costs The Company records the costs associated with research, nonclinical and clinical trials, and manufacturing development as incurred. These costs are a significant component of the Company’s research and development expenses, with a substantial portion of the Company’s on-going research and development activities conducted by third party service providers, including contract research and manufacturing organizations. The Company accrues for expenses resulting from obligations under agreements with contract research organizations (“CROs”), contract manufacturing organizations (“CMOs”), and other outside service providers for which payment flows do not match the periods over which materials or services are provided to the Company. Accruals are recorded based on estimates of services received and efforts expended pursuant to agreements established with CROs, CMOs, and other outside service providers. These estimates are typically based on contracted amounts applied to the proportion of work performed and determined through analysis with internal personnel and external service providers as to the progress or stage of completion of the services. The Company makes significant judgments and estimates in determining the accrual balance in each reporting period. In the event advance payments are made to a CRO, CMO, or outside service provider, the payments will be recorded as a prepaid asset which will be amortized or expensed as the contracted services are performed. As actual costs become known, the Company adjusts its prepaids and accruals. Inputs, such as the services performed, the number of patients enrolled, or the trial duration, may vary from the Company’s estimates, resulting in adjustments to research and development expense in future periods. Changes in these estimates that result in material changes to the Company’s accruals could materially affect the Company’s results of operations. To date, the Company has not experienced any material deviations between accrued and actual research and development expenses. Refer to Note 4. Accrued Expenses and Other Current Liabilities for additional discussion. |
Business Combinations | Business Combinations The Company accounts for business combinations in accordance with Accounting Standards Codification (“ASC”) Topic 805, Business Combinations , and as further defined by Accounting Standards Update (“ASU”) 2017-01, Business Combinations (Topic 805) , which requires the purchase price to be measured at fair value. When the purchase consideration consists entirely of shares of our common stock, the Company calculates the purchase price by determining the fair value, as of the acquisition date, of shares issued in connection with the closing of the acquisition and, if the transaction involves contingent consideration based on achievement of milestones or earn-out events, the probability-weighted fair value, as of the acquisition date, of shares issuable upon the occurrence of future events or conditions pursuant to the terms of the agreement governing the business combination. If the transaction involves such contingent consideration, our calculation of the purchase price involves probability inputs that are highly judgmental due to the inherent unpredictability of drug development, particularly by development-stage companies. The Company recognizes estimated fair values of the tangible assets and intangible assets acquired, including in process research and development (“IPR&D”), and liabilities assumed as of the acquisition date, and we record as goodwill any amount of the purchase price of the tangible and intangible assets acquired and liabilities assumed in excess of the fair value. |
License and Collaboration Agreements | License and Collaboration Agreements From time to time the Company enters and may continue to enter into license and collaboration agreements with third parties whereby the Company purchases the rights to develop, market, sell and/or distribute the underlying pharmaceutical products or drug candidates. Pursuant to these agreements, the Company may be required to make up-front payments, milestone payments contingent upon the achievement of certain pre-determined criteria, royalty payments based on specified sales levels of the underlying products, and/or certain other payments. Up-front payments are either expensed immediately as research and development or capitalized. The determination to capitalize amounts related to licenses is based on management’s judgments with respect to stage of development, the nature of the rights acquired, alternative future uses, developmental and regulatory issues and challenges, the net realizable value of such amounts based on projected sales of the underlying products, the commercial status of the unde rlying products, and/or various other competitive factors. Milestone payments made prior to regulatory approval are generally expensed as incurred and milestone payments made subsequent to regulatory approval are generally capitalized as an intangible asset. Royalty payments are expensed as incurred. Other payments made pursuant to license and collaboration agreements, which are generally related to research and development activities, are expensed as incurred. |
Goodwill and Acquired In-Process Research and Development | Goodwill and Acquired In-Process Research and Development In accordance with ASC Topic 350, Intangibles – Goodwill and Other , the Company's acquired IPR&D and goodwill, when applicable, is determined to have indefinite lives and, therefore, is not amortized. Instead, it is tested for impairment annually and between annual tests if the Company becomes aware of an event or a change in circumstances that would indicate the carrying value may be impaired. For instance, based upon the ultimate scope and scale of the COVID-19 global pandemic, there may be materially negative impacts to the assumptions made with respect to our IPR&D assets that could result in an impairment of such assets. With respect to the impairment testing of acquired IPR&D, ASU 2011-08, Intangibles – Goodwill and Other (Topic 350): Testing Goodwill for Impairment , and ASU 2012-02, Intangibles – Goodwill and Other (Topic 350): Testing Indefinite-Lived Intangible Assets for Impairment , provides for a two-step impairment process with the option to first assess qualitative factors to determine whether the existence of events or circumstances leads to the determination that it is more-likely-than not (that is, a likelihood of more than 50%) that acquired IPR&D is impaired. If the Company chooses to first assess qualitative factors and it determines that it is more-likely-than not acquired IPR&D is not impaired, the Company is not required to take further action to test for impairment. ASU 2017-04, Intangibles – Goodwill and Other (Topic 350): Simplifying the Test for Goodwill Impairment , outlines an impairment model providing us the option to implement a one-step method for determining impairment of goodwill, thereby simplifying the subsequent measurement of goodwill by eliminating Step 2 (quantitative calculation of measuring a goodwill impairment loss by comparing the implied fair value of a reporting unit’s goodwill with the carrying amount of that goodwill) from the goodwill impairment test. Under the amendments in this guidance, an entity should perform its annual or interim goodwill impairment test by comparing the fair value of a reporting unit with its carrying amount. An entity should recognize an impairment charge for the amount by which the carrying amount exceeds the reporting unit’s fair value; however, the loss recognized should not exceed the total amount of goodwill allocated to that reporting unit. Additionally, an entity should consider income tax effects from any tax-deductible goodwill on the carrying amount of the reporting unit when measuring the goodwill impairment loss, if applicable. When the Company performs a quantitative assessment of acquired IPR&D, it compares its carrying value to its estimated fair value to determine whether an impairment exists. Due to a lack of Level 1 or Level 2 inputs, the Multi-Period Excess Earnings Method (“MPEEM”), which is a form of the income approach, was used to estimate the fair value of acquired IPR&D when performing a quantitative assessment. Under the MPEEM, the fair value of an intangible asset is equal to the present value of the asset’s projected incremental after-tax cash flows (excess earnings) remaining after deducting the market rates of return on the estimated value of contributory assets (contributory charge) over its remaining useful life. The Company evaluates potential impairment of its acquired IPR&D annually on September 30, utilizing a qualitative approach and determining if it was more-likely-than not that the fair value was impaired. We evaluate potential impairment of our acquired goodwill, if any, annually on or around June 30, performing the quantitative analysis based upon market capitalization. Our determinations as to whether, and if so, the extent to which goodwill and acquired IPR&D become impaired are highly judgmental and, in the case of applying the MPEEM approach to estimate fair value, are based on significant assumptions regarding our projected future financial condition and operating results, changes in the manner of our use of the acquired assets, development of our acquired assets or our overall business strategy, and regulatory, market, and economic environment and trends . If the associated research and development effort is abandoned, the related asset will be written-off, and the Company will record a non-cash impairment loss on its consolidated statements of operations and comprehensive loss. For those products that reach commercialization, the IPR&D asset will be amortized over its estimated useful life. Refer to Note 8. Fair Value Measurements – Assets and Liabilities Measured at Fair Value on a Nonrecurring Basis for additional discussion. |
Manufacturing and Other Commitments and Contingencies | Manufacturing and Other Commitments and Contingencies The Company is subject to various royalties and manufacturing and development payments related to its product candidate, molgramostim. Under a manufacture and supply agreement with the active pharmaceutical ingredients (“API”) manufacturer for molgramostim, Savara must make certain payments to the API manufacturer upon achievement of the milestones outlined in the table set forth below. Additionally, upon first receipt of marketing approval by Savara from a regulatory authority in a country for a product containing the API for therapeutic use in humans and ending the earlier of (i) ten (10) years thereafter or (ii) the date a biosimilar of such product is first sold in such country, Savara shall pay the API manufacturer a royalty equal to low-single digits of the net sales in that country. The Company is also subject to certain contingent milestone payments, disclosed in the following table, payable to the manufacturer of the nebulizer used to administer molgramostim. The change in the amount of the milestone payments from December 31, 2021 to December 31, 2022 was related to foreign currency translation fluctuations. 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. Manufacturing, Development, and Other Contingent Milestone Payments (in thousands): December 31, 2022 Molgramostim manufacturer: Achievement of certain milestones related to validation of API and regulatory approval of $ 2,300 Molgramostim nebulizer manufacturer: Achievement of various development activities and regulatory approval of nebulizer utilized 536 Total manufacturing and other commitments $ 2,836 The milestone commitments disclosed above reflect the activities that have (i) not been met or incurred; (ii) not been remunerated; and (iii) not accrued, as the activities are not deemed probable or reasonably estimable, as of December 31, 2022. On December 10, 2020, the Company announced that the Phase 3 trial of vancomycin in people living with cystic fibrosis who have MRSA lung infection did not meet the primary endpoint. On January 7, 2021 the Company issued a termination notice to GlaxoSmithKline Trading Services Limited (“GSK”), which manufactures the drug product from bulk vancomycin powder. On January 26, 2021, the Company and GSK entered a change order for termination costs associated with the closeout and wind-down of vancomycin activities. During the year ended December 31, 2021, the Company paid approximately $ 0.8 million of research and development expense related to the termination of the manufacturing agreement. |
Tax Credit Receivable | Tax Credit Receivable The Company has recorded a Danish tax credit earned by its subsidiary, Savara ApS, as of December 31, 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 $ 0.8 million which was received in the fourth quarter of 2022. During the year ended December 31, 2022 , the Company generated a Danish tax credit of $ 0.8 million which is expected to be received in the fourth quarter of 2023. |
Leases | Leases The Company accounts for a contract as a lease when it has the right to control the asset for a period of time while obtaining substantially all of the asset's economic benefits in accordance with ASU 2016-02, Leases (Topic 842), as codified in ASC 842, Leases . Lease right-of-use assets and liabilities are initially recorded on the lease commencement date based on the present value of lease payments over the lease term. The present value of lease payments is determined by using the interest rate implicit in the lease, if that rate is readily determinable; otherwise, the Company uses its estimated secured incremental borrowing rate for that lease term. Leases may include renewal, purchase or termination options that can extend or shorten the term of the lease. The exercise of those options is at the Company's sole discretion and is evaluated at inception and throughout the contract to determine if a modification of the lease term is required. In addition to rent, the leases may require the Company to pay additional amounts for taxes, insurance, maintenance, and other expenses, which are generally referred to as non-lease components. The Company has elected to not separate lease and non-lease components. Only the fixed costs for lease components and their associated non-lease components are accounted for as a single lease component and recognized as part of a right-of-use asset and liability. Rent expense is recognized on a straight-line basis over the reasonably assured lease term based on the total lease payments and is included in operating expenses in the consolidated statements of operations and comprehensive loss. The Company has made an accounting policy election providing that leases with an initial term of 12 months or less are not recorded as a lease right-of-use asset and corresponding liability in accordance with ASC 842, Leases ; those lease payments are recognized in the consolidated statements of operations and comprehensive loss on a straight-line basis over the lease term. Refer to Note 10. Commitments – Operating Leases for additional discussion. |
Segment Reporting | Segment Reporting Operating segments are identified as components of an enterprise about which separate discrete financial information is available for evaluation by the chief operating decision maker, or decision making group, in making decisions on how to allocate resources and assess performance. Our chief operating decision maker is the chief executive officer. We have one operating segment, specialty pharmaceuticals within the respiratory system. |
Property and Equipment | Property and Equipment Property and equipment are stated at cost, net of accumulated depreciation. Depreciation is determined on a straight-line basis over the estimated useful lives of the assets, which range from three to five years . Repairs and maintenance that do not improve or extend the useful life of the respective asset are charged to expense as incurred. Refer to Note 6. Property and Equipment, net for additional discussion. |
Patents and Intellectual Property | Patents and Intellectual Property As the Company’s products are currently under research and development and are not currently approved for market, costs incurred in connection with patent applications are expensed as incurred due to the uncertainty of the future economic benefits of the underlying patents and intellectual property. |
Fair Value of Financial Instruments | Fair Value of Financial Instruments The accounting standard for fair value measurements provides a framework for measuring fair value and requires disclosures regarding fair value measurements. Fair value is defined as the price that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date, based on the Company’s principal or, in absence of a principal, most advantageous market for the specific asset or liability. The Company uses a three-tier fair value hierarchy to classify and disclose all assets and liabilities measured at fair value on a recurring basis, as well as assets and liabilities measured at fair value on a non-recurring basis, in periods subsequent to their initial measurement. The hierarchy requires the Company to use observable inputs when available, and to minimize the use of unobservable inputs, when determining fair value. The three tiers are defined as follows: • Level 1 – Observable inputs that reflect quoted market prices (unadjusted) for identical assets or liabilities in active markets; • Level 2 – Observable inputs other than quoted prices in active markets that are observable either directly or indirectly in the marketplace for identical or similar assets and liabilities; and • Level 3 – Unobservable inputs that are supported by little or no market data, which require the Company to develop its own assumptions. Financial instruments carried at fair value include cash and cash equivalents, short-term investments, and foreign exchange derivatives not designated as hedging instruments. Financial instruments not carried at fair value include accounts payable and accrued liabilities. The carrying amounts of these financial instruments approximate fair value due to the highly liquid nature of these short-term instruments. Refer to Note 8. Fair Value Measurements for additional discussion. |
Revenue Recognition | Revenue Recognition The Company records revenue based on a five-step model in accordance with ASC 606, Revenue from Contracts with Customers . To date, the Company has not generated any product revenue. The Company’s ability to generate product revenues, which the Company does not expect will occur in the next several years, if ever, will depend heavily on the successful development, regulatory approval, and eventual commercialization of the Company’s product candidates. |
Net Loss per Share | Net Loss per Share Basic net loss attributable to common stockholders per share is calculated by dividing the net loss attributable to common stockholders by the weighted average number of shares of common stock and pre-funded warrants outstanding during the period without consideration of common stock equivalents. Since the Company was in a loss position for all periods presented, diluted net loss per share is the same as basic net loss per share for all periods presented as the inclusion of all potential dilutive securities would have been antidilutive. Refer to Note 14. Net Loss per Share for additional discussion. |
Stock-Based Compensation | Stock-Based Compensation The Company recognizes the cost of stock-based awards granted to employees based on the estimated grant-date fair value of the awards. The value of the portion of the award is recognized as expense ratably over the requisite service period. The Company recognizes the compensation costs for awards that vest over several years on a straight-line basis over the vesting period. Forfeitures are recognized when they occur, which may result in the reversal of compensation costs in subsequent periods as the forfeitures arise. In addition, the Company accounts for any modifications to stock-based awards in accordance with ASC Topic 718, Compensation – Stock Compensation . Refer to Note 12. Stock-Based Compensation for additional discussion. |
Income Taxes | Income Taxes The Company uses the asset and liability method of accounting for income taxes. Under this method, deferred tax assets and liabilities are recognized for the expected future tax consequences of temporary differences between the carrying amounts and the tax basis of assets and liabilities. Deferred tax assets and liabilities are measured using enacted tax rates expected to apply to taxable income in the years in which those temporary differences are expected to be recovered or settled. The effect of a change in tax rates on deferred tax assets and liabilities will be recognized in the period that includes the enactment date. A valuation allowance is established against the deferred tax assets to reduce their carrying value to an amount that is more-likely-than not to be realized. Refer to Note 13. Income Taxes for additional discussion. |
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 consolidated financial statements. |
Prepaid Expenses and Other Cu_2
Prepaid Expenses and Other Current Assets (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Prepaid Expense and Other Assets, Current [Abstract] | |
Schedule of Prepaid Expenses and Other Current Assets | Prepaid expenses, consisted of (in thousands): December 31, 2022 2021 Prepaid contracted research and development costs $ 1,822 $ 1,902 R&D tax credit receivable 792 838 VAT receivable 162 306 Prepaid insurance 231 427 Deposits and other 71 356 Total prepaid expenses and other current assets $ 3,078 $ 3,829 |
Accrued Expenses and Other Cu_2
Accrued Expenses and Other Current Liabilities (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Payables and Accruals [Abstract] | |
Summary of Accrued Expenses and Other Current Liabilities | Accrued expenses and other liabilities, consisted of (in thousands): December 31, 2022 2021 Accrued compensation $ 2,365 $ 2,526 Accrued contracted research and development costs 1,322 1,623 Accrued general and administrative costs 782 600 Lease liability 64 135 Total accrued expenses and other current liabilities $ 4,533 $ 4,884 |
Short-term Investments (Tables)
Short-term Investments (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Investments, Debt and Equity Securities [Abstract] | |
Summary of Major Security Type of Investments | The following table summarizes, by major security type, the Company’s investments (in thousands): As of December 31, 2022 Amortized Cost Gross Unrealized Gains Gross Unrealized Losses Fair Value Short-term investments U.S. government securities $ 73,784 $ 8 $ ( 16 ) $ 73,776 Asset backed securities — — — — Corporate securities — — — — Commercial paper — — — — Total short-term investments (*) $ 73,784 $ 8 $ ( 16 ) $ 73,776 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 * Designated custodial institution, U.S. Bank, N.A. |
Property and Equipment, Net (Ta
Property and Equipment, Net (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Property, Plant and Equipment [Abstract] | |
Property and Equipment, Net | Property and equipment, net consisted of (in thousands): December 31, 2022 2021 Research and development equipment $ 1,102 $ 1,102 Equipment 666 746 Furniture and fixtures 61 151 Leasehold improvements 145 153 Total property and equipment 1,974 2,152 Less accumulated depreciation ( 1,923 ) ( 2,079 ) Property and equipment, net $ 51 $ 73 |
Debt Facility (Tables)
Debt Facility (Tables) | 12 Months Ended |
Dec. 31, 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, 2023 $ — 2024 — 2025 — 2026 17,667 2027 9,562 Total future minimum payments 27,229 Unamortized end of term charge ( 630 ) Debt issuance costs ( 478 ) Debt discount related to warrants ( 43 ) Total debt 26,078 Current portion of long-term debt — Long-term debt $ 26,078 |
Fair Value Measurements (Tables
Fair Value Measurements (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Fair Value Disclosures [Abstract] | |
Summary of Fair Value of Financial Instruments | The fair value of these instruments as of December 31, 2022 and 2021 was as follows (in thousands): Quoted Prices in Significant Significant Total As of December 31, 2022 Cash equivalents (*): U.S. Treasury money market funds $ 48,804 $ — $ — $ 48,804 Short-term investments (*): U.S. government securities 73,776 — — 73,776 Asset backed securities — — — — Corporate securities — — — — Commercial paper — — — — 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 * Designated custodial institution, U.S. Bank, N.A. |
Stockholders_ Equity (Tables)
Stockholders’ Equity (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Equity [Abstract] | |
Summary of Net Proceeds from Private Placement | The net proceeds from the Private Placement were allocated among the instruments based upon their relative fair values at December 24, 2019 resulting in carry values of the respective instruments as follows (in thousands): Financial instruments Relative Fair Value Common stock and Pre-Funded PIPE Warrants $ 11,713 Milestone Warrants 13,534 Total Net Proceeds from Private Placement $ 25,247 |
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 |
Summary of Company's Common Stock | The following is a summary of the Company’s common stock at December 31, 2022 and 2021: December 31 2022 2021 Common stock authorized 300,000,000 300,000,000 Common stock outstanding 114,046,345 114,036,892 |
Company's Shares of Common Stock Reserved for Issuance | The Company’s shares of common stock reserved for issuance as of December 31, 2022 and 2021 were as follows: December 31, 2022 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 7,933,184 6,218,841 Issued and non-vested RSUs 1,942,250 1,272,375 Total shares reserved 48,683,936 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 December 31, 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 ( 648 ) 38 ( 610 ) Balance, December 31, 2022 $ ( 594 ) $ ( 11 ) $ ( 605 ) |
Commitments (Tables)
Commitments (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Commitments and Contingencies Disclosure [Abstract] | |
Schedule of Maturity Analysis of Annual Undiscounted Cash Flows Reconciled to Carrying Value of Operating Lease Liabilities | Year ending December 31, 2023 $ 63 2024 54 Total future minimum lease payments $ 117 Less imputed interest ( 7 ) Total $ 110 |
Schedule of Lease Cost and Other Information | Operating cash flows from operating leases $ 151 Weighted-average remaining lease term (in months) - operating leases 21.0 Weighted-average discount rate - operating leases 7.8 % |
Schedule of Manufacturing, Development, and Other Contingent Milestone Payments | Manufacturing, Development, and Other Contingent Milestone Payments (in thousands): December 31, 2022 Molgramostim manufacturer: Achievement of certain milestones related to validation of API and regulatory approval of $ 2,300 Molgramostim nebulizer manufacturer: Achievement of various development activities and regulatory approval of nebulizer utilized 536 Total manufacturing and other commitments $ 2,836 |
Stock-Based Compensation (Table
Stock-Based Compensation (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Share-Based Payment Arrangement [Abstract] | |
Summary of Assumptions Used for Estimating the Fair Value of Stock Options Granted to Employees | The following table summarizes the assumptions used for estimating the fair value of stock options granted to employees for the years ended December 31, 2022 and 2021: 2022 2021 Risk-free interest rate 2.11 % - 3.94 % 0.77 % - 1.27 % Expected term (years) 6.06 6.06 - 6.07 Expected volatility 88.5 % - 97.44 % 79.7 % - 91.2 % Dividend yield 0 % 0 % |
Summary of Stock Option Activity and RSU Activity | The following tables provide a summary for stock option and RSU activity for the year ended December 31, 2022: Stock Options: Shares Underlying Option Awards Weighted-Average Exercise Price Weighted-Average Remaining Contractual Life Aggregate Intrinsic Value (in 000's) Outstanding at December 31, 2021 6,218,841 $ 2.25 8.59 $ 354 Granted 2,812,000 1.48 6.06 Exercised ( 2,344 ) 0.65 2 Expired/cancelled/forfeited ( 1,095,313 ) 1.51 Outstanding at December 31, 2022 7,933,184 $ 2.08 8.40 $ 1,440 Options exercisable at December 31, 2022 3,330,099 $ 3.01 7.16 $ 676 Vested and expected to vest at December 31, 2022 7,933,184 $ 2.08 8.40 $ 1,440 RSUs: Shares Weighted-Average Grant Date Fair Value Outstanding at December 31, 2021 1,272,375 $ 1.20 Granted 949,000 1.49 Vested ( 8,672 ) 3.35 Expired/cancelled/forfeited ( 270,453 ) 1.30 Outstanding at December 31, 2022 1,942,250 $ 1.32 |
Stock-based Compensation Expense included in Accompanying Statements of Operations and Comprehensive Loss | Stock-based compensation expense is included in the following line items in the accompanying statements of operations and comprehensive loss for the years ended December 31, 2022 and 2021 (in thousands): Year ended December 31, 2022 2021 Research and development $ 448 $ 1,286 General and administrative 1,593 1,974 Total stock-based compensation $ 2,041 $ 3,260 |
Income Taxes (Tables)
Income Taxes (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Income Tax Disclosure [Abstract] | |
Components of Loss Before Income Taxes | The components of loss before income taxes for the years ended December 31, 2022 and 2021 are as follows (in thousands): December 31, 2022 2021 Domestic $ ( 29,326 ) $ ( 28,705 ) Foreign ( 8,824 ) ( 14,309 ) Total $ ( 38,150 ) $ ( 43,014 ) |
Components of Benefit for Income Taxes | The components of the benefit for income taxes are as follows for the years ended December 31, 2022 and 2021 (in thousands): December 31, 2022 2021 Current: Federal $ — $ — State — — Foreign — — Total Current — — Deferred: Federal — — State — — Foreign — — Total Deferred — — Total income tax expense (benefit) $ — $ — |
Reconciliation of Expected Income Tax | A reconciliation of the expected income tax results computed using the federal statutory income tax rate to the Company’s effective income tax rate is as follows for the years ended December 31, 2022 and 2021 (in thousands): December 31, 2022 2021 Income tax benefit computed at federal statutory tax rate $ ( 8,011 ) $ ( 9,033 ) Change in valuation allowance 4,286 ( 12,253 ) Orphan drug & research credits generated ( 1,677 ) ( 1,966 ) Orphan drug & research credit expense disallowance — — Impact of foreign operations ( 16 ) ( 177 ) Sec. 382 Limitation — 25,249 Foreign deferred tax asset - true up 2,021 ( 3,833 ) Imputed interest 1,006 1,253 Permanent differences 2,213 738 Other 178 22 Total $ — $ — |
Significant Components of Deferred Tax Assets and Liabilities | Significant components of the Company’s deferred tax assets and liabilities are as follows (in thousands): December 31, 2022 2021 Deferred tax liabilities: Prepaid assets $ — $ — Other 329 574 Total deferred tax liabilities 329 574 Deferred tax assets: Net operating loss carryforwards 38,969 36,298 Intangible assets 267 5,380 Amortization 1,165 1,212 Credit carryforwards 5,966 4,351 Section 174 research and development expenses 3,663 — Accrued liabilities & other 1,203 1,107 Total deferred tax assets 51,233 48,348 Subtotal 50,904 47,774 Valuation allowance ( 50,904 ) ( 47,774 ) Net deferred taxes $ — $ — |
Net Loss Per Share (Tables)
Net Loss Per Share (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Earnings Per Share [Abstract] | |
Schedule of Potentially Dilutive Securities | As of December 31, 2022 and 2021, potentially dilutive securities include: Year ended December 31, 2022 2021 Awards under equity incentive plan 7,933,184 6,218,841 Non-vested restricted shares and restricted stock units 1,942,250 1,272,375 Warrants to purchase common stock 77,793 77,793 Total 9,953,227 7,569,009 |
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 years ended December 31, 2022 and 2021 (in thousands, except share and per share amounts): Year ended December 31, 2022 2021 Net loss $ ( 38,150 ) $ ( 43,014 ) Net loss attributable to common stockholders $ ( 38,150 ) $ ( 43,014 ) Undistributed earnings and net loss attributable to $ ( 38,150 ) $ ( 43,014 ) Weighted-average common shares outstanding, basic 152,771,817 133,919,145 Basic and diluted EPS $ ( 0.25 ) $ ( 0.32 ) |
Description of Business and B_2
Description of Business and Basis of Presentation - Additional Information (Detail) | 12 Months Ended |
Dec. 31, 2022 USD ($) Segment | |
Description Of Business And Basis Of Presentation [Line Items] | |
Number of operating segments | Segment | 1 |
Product [Member] | |
Description Of Business And Basis Of Presentation [Line Items] | |
Revenue from inception to date | $ | $ 0 |
Summary of Significant Accoun_3
Summary of Significant Accounting Policies - Additional Information (Detail) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2022 USD ($) Segment | Dec. 31, 2021 USD ($) | Mar. 10, 2023 USD ($) | |
Summary Of Significant Accounting Policies [Line Items] | |||
Accumulated deficit | $ (338,671) | $ (300,521) | |
Cash from operations | (34,554) | (40,081) | |
Cash and cash equivalents | 52,100 | 34,012 | |
Short-term investments | $ 73,776 | $ 127,159 | |
Cash and cash equivalents with original maturities | three months or less | ||
Number of operating segments | Segment | 1 | ||
Minimum [Member] | |||
Summary Of Significant Accounting Policies [Line Items] | |||
Estimated useful lives of assets | 3 years | ||
Maximum [Member] | |||
Summary Of Significant Accounting Policies [Line Items] | |||
Estimated useful lives of assets | 5 years | ||
Maximum [Member] | Silicon Valley Bank [Member] | Subsequent Event [Member] | |||
Summary Of Significant Accounting Policies [Line Items] | |||
Deposits insured by FDIC limit | $ 250 |
Prepaid Expenses and Other Cu_3
Prepaid Expenses and Other Current Assets - Summary of Prepaid Expenses and Other Current Assets (Detail) - USD ($) $ in Thousands | Dec. 31, 2022 | Dec. 31, 2021 |
Prepaid Expense and Other Assets, Current [Abstract] | ||
Prepaid contracted research and development costs | $ 1,822 | $ 1,902 |
R&D tax credit receivable | 792 | 838 |
VAT receivable | 162 | 306 |
Prepaid insurance | 231 | 427 |
Deposits and other | 71 | 356 |
Total prepaid expenses and other current assets | $ 3,078 | $ 3,829 |
Prepaid Expenses and Other Cu_4
Prepaid Expenses and Other Current Assets - Additional Information (Details) - Savara ApS [Member] - USD ($) $ in Millions | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Prepaid Expenses And Other Current Assets [Line Items] | ||
Effective Income Tax Rate Reconciliation, Tax Credit, Research, Percent | 22% | |
R&D Tax Credit Receivable [Member] | ||
Prepaid Expenses And Other Current Assets [Line Items] | ||
Research and development tax credits receivable | $ 0.8 | |
Other Non-currentAssets [Member] | ||
Prepaid Expenses And Other Current Assets [Line Items] | ||
Research and development tax credits receivable | $ 0.8 |
Accrued Expenses and Other Cu_3
Accrued Expenses and Other Current Liabilities - Summary of Accrued Expenses and Other Current Liabilities (Detail) - USD ($) $ in Thousands | Dec. 31, 2022 | Dec. 31, 2021 |
Payables and Accruals [Abstract] | ||
Accrued compensation | $ 2,365 | $ 2,526 |
Accrued contracted research and development costs | 1,322 | 1,623 |
Accrued general and administrative costs | 782 | 600 |
Lease liability | 64 | 135 |
Total accrued expenses and other current liabilities | $ 4,533 | $ 4,884 |
Short-term Investments - Summar
Short-term Investments - Summary of Major Security and Type of Investments (Detail) - USD ($) $ in Thousands | Dec. 31, 2022 | Dec. 31, 2021 | |
Schedule Of Available For Sale Securities [Line Items] | |||
Amortized Cost | [1] | $ 73,784 | $ 127,206 |
Gross Unrealized Gains | [1] | 8 | |
Gross Unrealized Losses | [1] | (16) | (47) |
Fair Value | [1] | 73,776 | 127,159 |
U.S. Government Securities [Member] | |||
Schedule Of Available For Sale Securities [Line Items] | |||
Amortized Cost | 73,784 | 12,205 | |
Gross Unrealized Gains | 8 | ||
Gross Unrealized Losses | (16) | (15) | |
Fair Value | $ 73,776 | 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 | 54,557 | ||
Fair Value | $ 54,557 | ||
[1] * Designated custodial institution, U.S. Bank, N.A. |
Short-term Investments - Additi
Short-term Investments - Additional Information (Detail) - USD ($) | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Investments, Debt and Equity Securities [Abstract] | ||
Realized gains or losses on investments | $ 0 | $ 0 |
Property and Equipment, Net - P
Property and Equipment, Net - Property and Equipment, Net (Detail) - USD ($) $ in Thousands | Dec. 31, 2022 | Dec. 31, 2021 |
Property Plant And Equipment [Line Items] | ||
Property and equipment, gross | $ 1,974 | $ 2,152 |
Less accumulated depreciation | (1,923) | (2,079) |
Property and equipment, net | 51 | 73 |
Research and Development Equipment [Member] | ||
Property Plant And Equipment [Line Items] | ||
Property and equipment, gross | 1,102 | 1,102 |
Equipment [Member] | ||
Property Plant And Equipment [Line Items] | ||
Property and equipment, gross | 666 | 746 |
Furniture and Fixtures [Member] | ||
Property Plant And Equipment [Line Items] | ||
Property and equipment, gross | 61 | 151 |
Leasehold Improvements [Member] | ||
Property Plant And Equipment [Line Items] | ||
Property and equipment, gross | $ 145 | $ 153 |
Debt Facility - Additional Info
Debt Facility - Additional Information (Detail) - USD ($) | 12 Months Ended | |||
Apr. 21, 2022 | Apr. 28, 2017 | Dec. 31, 2022 | ||
Line Of Credit Facility [Line Items] | ||||
Repayment of outstanding amounts under Loan Agreement | [1] | $ 26,350,000 | ||
Loan and Security Agreement [Member] | Silicon Valley Bank [Member] | ||||
Line Of Credit Facility [Line Items] | ||||
Loan agreement amendment date | Oct. 31, 2017 | |||
Loan agreement amendment date one | Dec. 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] | ||||
Line Of Credit Facility [Line Items] | ||||
Loan agreement amendment date | Apr. 21, 2022 | |||
Principal amount | $ 26,500,000 | $ 25,000,000 | ||
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. | |||
Frequency of principal plus interest repayment period | equal monthly installments | |||
Debt instrument principal and interest payment period | 12 months | |||
Interest rate, basis spread | 0.50% | |||
Repayment of outstanding amounts under Loan Agreement | 25,000,000 | |||
Prepayment fee | 100,000 | |||
End of term charge | $ 1,400,000 | |||
Debt instrument, maturity rate range, end | Apr. 21, 2027 | |||
Interest only extension cash percentage of outstanding principal | 1.75% | |||
Debt instrument, interest rate | 3% | |||
Percentage of obligation to pay closing fees and final payment | 2.75% | |||
Extinguishment Of Debt | $ 0 | |||
Payments of Debt Issuance Costs | $ 100,000 | |||
Loan and Security Agreement [Member] | Silicon Valley Bank [Member] | Term Loan [Member] | Maximum [Member] | ||||
Line Of Credit Facility [Line Items] | ||||
Debt instrument covenants cash and cash equivalents threshold limit | $ 40,000,000 | |||
Loan and Security Agreement [Member] | Silicon Valley Bank [Member] | Before First Anniversary Closing Date [Member] | Term Loan [Member] | ||||
Line Of Credit Facility [Line Items] | ||||
Prepayment fee percentage | 4.25% | |||
Loan and Security Agreement [Member] | Silicon Valley Bank [Member] | After First And Before Second Anniversary Closing Date | Term Loan [Member] | ||||
Line Of Credit Facility [Line Items] | ||||
Prepayment fee percentage | 1% | |||
[1] As discussed in Note 7. Debt Facility , 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. |
Debt Facility - Carrying Value
Debt Facility - Carrying Value and Future Minimum Payments (Detail) - USD ($) $ in Thousands | Dec. 31, 2022 | Dec. 31, 2021 |
Debt Disclosure [Abstract] | ||
2026 | $ 17,667 | |
2027 | 9,562 | |
Total future minimum payments | 27,229 | |
Unamortized end of term charge | (630) | |
Debt issuance costs | (478) | |
Debt discount related to warrants | (43) | |
Total debt | 26,078 | |
Current portion of long-term debt | $ (8,333) | |
Long-term debt | $ 26,078 | $ 17,323 |
Fair Value Measurements - Summa
Fair Value Measurements - Summary of Fair Value of Financial Instruments (Detail) - Fair Value, Measurements, Recurring [Member] - USD ($) $ in Thousands | Dec. 31, 2022 | Dec. 31, 2021 | |
U.S. Treasury Money Market Funds [Member] | |||
Cash equivalents: | |||
Cash equivalents | [1] | $ 48,804 | $ 30,853 |
U.S. Government Securities [Member] | |||
Short-term investments: | |||
Short-term investments | [1] | 73,776 | 12,190 |
Asset Backed Securities [Member] | |||
Short-term investments: | |||
Short-term investments | [1] | 11,346 | |
Corporate Securities [Member] | |||
Short-term investments: | |||
Short-term investments | [1] | 49,066 | |
Commercial Paper [Member] | |||
Short-term investments: | |||
Short-term investments | [1] | 54,557 | |
Quoted Prices in Active Markets for Identical Assets (Level 1) [Member] | U.S. Treasury Money Market Funds [Member] | |||
Cash equivalents: | |||
Cash equivalents | [1] | 48,804 | 30,853 |
Quoted Prices in Active Markets for Identical Assets (Level 1) [Member] | U.S. Government Securities [Member] | |||
Short-term investments: | |||
Short-term investments | [1] | $ 73,776 | 12,190 |
Significant Other Observable Inputs (Level 2) [Member] | Asset Backed Securities [Member] | |||
Short-term investments: | |||
Short-term investments | [1] | 11,346 | |
Significant Other Observable Inputs (Level 2) [Member] | Corporate Securities [Member] | |||
Short-term investments: | |||
Short-term investments | [1] | 49,066 | |
Significant Other Observable Inputs (Level 2) [Member] | Commercial Paper [Member] | |||
Short-term investments: | |||
Short-term investments | [1] | $ 54,557 | |
[1] * Designated custodial institution, U.S. Bank, N.A. |
Fair Value Measurements - Addit
Fair Value Measurements - Additional Information (Detail) - USD ($) | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Fair value, assets, transfers into level 3, amount | $ 0 | $ 0 |
Fair value, assets, transfers out of level 3, amount | 0 | 0 |
IPR&D | 10,656,000 | 11,274,000 |
Increase (decrease) in carrying value of IPR&D due to foreign currency translation | $ (600,000) | $ (900,000) |
Stockholders' Equity - Addition
Stockholders' Equity - Additional Information (Detail) - USD ($) $ / shares in Units, $ in Thousands | 12 Months Ended | |||||||||
Aug. 13, 2021 | Jul. 16, 2021 | Jul. 12, 2021 | Mar. 15, 2021 | Dec. 24, 2019 | Jul. 13, 2018 | Dec. 31, 2022 | Dec. 31, 2021 | Jul. 06, 2021 | ||
Class Of Warrant Or Right [Line Items] | ||||||||||
Aggregate number of common stock | 48,683,936 | 46,299,718 | ||||||||
Common stock, par value | $ 0.001 | $ 0.001 | ||||||||
Net proceeds | $ 25,247 | |||||||||
Net proceeds after deducting underwriting discounts commissions and offering expenses | $ 122,231 | |||||||||
Value of shares sold prior to amendment | [1] | $ 122,231 | ||||||||
Common and preferred stock, shares authorized | 301,000,000 | |||||||||
Common Stock, Shares Authorized | 300,000,000 | 300,000,000 | ||||||||
Preferred stock, shares authorized | 1,000,000 | |||||||||
Preferred stock, par value | $ 0.001 | |||||||||
H.C. Wainwright & Co., LLC [Member] | ||||||||||
Class Of Warrant Or Right [Line Items] | ||||||||||
Common stock, par value | $ 0.001 | |||||||||
Termination of agreement | July 12, 2021 | |||||||||
Sales commissions in fixed percentage of gross proceeds per share | 3% | |||||||||
H.C. Wainwright & Co., LLC [Member] | Maximum [Member] | ||||||||||
Class Of Warrant Or Right [Line Items] | ||||||||||
Amount available to sell under equity program | $ 60,000 | |||||||||
Evercore Group L.L.C., [Member] | ||||||||||
Class Of Warrant Or Right [Line Items] | ||||||||||
Common stock, par value | $ 0.001 | |||||||||
Common stock sales agreement, effective date | Jul. 16, 2021 | |||||||||
Sales commissions in fixed percentage of gross proceeds per share | 3% | |||||||||
Common stock, shares sold | 0 | |||||||||
Evercore Group L.L.C., [Member] | Maximum [Member] | ||||||||||
Class Of Warrant Or Right [Line Items] | ||||||||||
Amount available to sell under equity program | $ 60,000 | |||||||||
Common Stock [Member] | ||||||||||
Class Of Warrant Or Right [Line Items] | ||||||||||
Common stock, shares issued | [1] | 57,479,978 | ||||||||
Value of shares sold prior to amendment | [1] | $ 57 | ||||||||
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 | |||||||||
Pre-Funded PIPE Warrants [Member] | ||||||||||
Class Of Warrant Or Right [Line Items] | ||||||||||
Aggregate number of common stock | 5,780,537 | 5,780,537 | ||||||||
Warrant Repurchase [Member] | ||||||||||
Class Of Warrant Or Right [Line Items] | ||||||||||
Common stock, par value | $ 0.15 | |||||||||
Warrants and rights outstanding | $ 3,900 | |||||||||
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 | |||||||||
Private Placement [Member] | ||||||||||
Class Of Warrant Or Right [Line Items] | ||||||||||
Common stock, par value | $ 0.001 | |||||||||
Net proceeds | $ 25,200 | |||||||||
Private Placement [Member] | Milestone Warrants [Member] | ||||||||||
Class Of Warrant Or Right [Line Items] | ||||||||||
Aggregate number of common stock | 32,577,209 | |||||||||
Net proceeds | $ 75,000 | |||||||||
Exercise price of warrants per share | $ 1.48 | |||||||||
Gross proceeds from issuance of warrants | $ 48,200 | |||||||||
Private Placement [Member] | Common Stock [Member] | ||||||||||
Class Of Warrant Or Right [Line Items] | ||||||||||
Common stock, shares issued | 9,569,430 | |||||||||
Share price | $ 1.745 | |||||||||
Private Placement [Member] | Pre-Funded PIPE Warrants [Member] | ||||||||||
Class Of Warrant Or Right [Line Items] | ||||||||||
Share price | $ 1.744 | |||||||||
Aggregate number of common stock | 5,780,537 | |||||||||
Public Offering of Common Stock [Member] | ||||||||||
Class Of Warrant Or Right [Line Items] | ||||||||||
Common stock, par value | $ 0.001 | |||||||||
Common stock, sale of stock, price per share | $ 1.45 | |||||||||
Common stock, shares issued to underwriters | 11,694,150 | |||||||||
Common stock, pre-funded warrants to purchase | 32,175,172 | |||||||||
Common Stock pre funded warrants exercise price | $ 0.001 | |||||||||
Common Stock pre funded warrants per warrant | $ 1.449 | |||||||||
Net proceeds after deducting underwriting discounts commissions and offering expenses | $ 122,200 | |||||||||
Common stock, shares sold | 57,479,978 | |||||||||
[1] As discussed in Note 9. 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. |
Stockholders' Equity - Summary
Stockholders' Equity - Summary of Net Proceeds from Private Placement (Detail) $ in Thousands | Dec. 24, 2019 USD ($) |
Class Of Warrant Or Right [Line Items] | |
Proceeds from Issuance of Private Placement | $ 25,247 |
Common Stock and Pre-Funded PIPE Warrants [Member] | |
Class Of Warrant Or Right [Line Items] | |
Proceeds from Issuance of Private Placement | 11,713 |
Milestone Warrants [Member] | |
Class Of Warrant Or Right [Line Items] | |
Proceeds from Issuance of Private Placement | $ 13,534 |
Shareholders' Equity - Summary
Shareholders' Equity - Summary of Net Proceeds after Deducting Underwriting Discounts Commissions and Offering Expenses (Details) $ in Thousands | 12 Months Ended |
Dec. 31, 2022 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 |
Stockholders' Equity - Summar_2
Stockholders' Equity - Summary of Company's Common Stock (Detail) - shares | Dec. 31, 2022 | Dec. 31, 2021 |
Equity [Abstract] | ||
Common stock authorized | 300,000,000 | 300,000,000 |
Common stock outstanding | 114,046,345 | 114,036,892 |
Stockholders' Equity - Company'
Stockholders' Equity - Company's Shares of Common Stock Reserved for Issuance (Detail) - shares | Dec. 31, 2022 | Dec. 31, 2021 |
Class Of Warrant Or Right [Line Items] | ||
Total shares reserved | 48,683,936 | 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 | 7,933,184 | 6,218,841 |
Issued and nonvested RSUs [Member] | ||
Class Of Warrant Or Right [Line Items] | ||
Total shares reserved | 1,942,250 | 1,272,375 |
Stockholders' Equity - Summar_3
Stockholders' Equity - Summary of Outstanding Warrants for Company's Common Stock (Detail) | 12 Months Ended |
Dec. 31, 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] | |
Shares Underlying Outstanding Warrants | 775,000 |
Exercise Price | $ / shares | $ 0.01 |
Expiration Date | 2024-10 |
Exercise Price Two [Member] | |
Class Of Warrant Or Right [Line Items] | |
Shares Underlying Outstanding Warrants | 24,725 |
Exercise Price | $ / shares | $ 2.87 |
Expiration Date | 2027-04 |
Exercise Price Three [Member] | |
Class Of Warrant Or Right [Line Items] | |
Shares Underlying Outstanding Warrants | 41,736 |
Exercise Price | $ / shares | $ 2.87 |
Expiration Date | 2027-06 |
Exercise Price Four [Member] | |
Class Of Warrant Or Right [Line Items] | |
Shares Underlying Outstanding Warrants | 11,332 |
Exercise Price | $ / shares | $ 2.87 |
Expiration Date | 2028-12 |
Exercise Price Five [Member] | |
Class Of Warrant Or Right [Line Items] | |
Shares Underlying Outstanding Warrants | 37,955,709 |
Exercise Price | $ / shares | $ 0.001 |
Expiration Date | None |
Stockholders' Equity - Componen
Stockholders' Equity - Components of Accumulated Other Comprehensive Income (Loss) (Detail) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Accumulated Other Comprehensive Income Loss [Line Items] | ||
Total Accumulated Other Comprehensive Income (Loss) | $ 5 | $ 942 |
Change | (610) | (937) |
Total Accumulated Other Comprehensive Income (Loss) | (605) | 5 |
Foreign Exchange Translation Adjustment [Member] | ||
Accumulated Other Comprehensive Income Loss [Line Items] | ||
Total Accumulated Other Comprehensive Income (Loss) | 54 | 941 |
Change | (648) | (887) |
Total Accumulated Other Comprehensive Income (Loss) | (594) | 54 |
Unrealized Gain (Loss) on ST Investments [Member] | ||
Accumulated Other Comprehensive Income Loss [Line Items] | ||
Total Accumulated Other Comprehensive Income (Loss) | (49) | 1 |
Change | 38 | (50) |
Total Accumulated Other Comprehensive Income (Loss) | $ (11) | $ (49) |
Commitments - Additional Inform
Commitments - Additional Information (Detail) - USD ($) | 1 Months Ended | 3 Months Ended | 12 Months Ended | ||||
Jul. 07, 2021 | Jun. 03, 2021 | Mar. 05, 2021 | Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2022 | Aug. 01, 2021 | |
Commitments And Contingencies [Line Items] | |||||||
Lease term | 36 months | 36 months | |||||
Lessee, Operating Lease, Existence of Option to Extend [true false] | true | ||||||
Lessee, Operating Lease, Option to Extend | The Company’s leases have lease terms that include options to extend (in some cases, for up to 36 months). The exercise of lease renewal and termination options are at the Company’s sole discretion with the exception of the Austin Texas lease, as amended, noted below. For purposes of calculating operating lease liabilities, the Company’s leases are deemed not to include an option to extend the lease term until it is reasonably certain that the Company will exercise that option. The Company has operating lease agreements with lease and non-lease components that are accounted for as a single lease component. | ||||||
Sublease expiry month and year | 2021-07 | ||||||
Lease termination fee paid | $ 20,000 | ||||||
Lease termination period | The term for the Current TX Lease is initially six months or June 30, 2023, at which point it converts to a month-to-month arrangement thereafter with termination rights upon thirty days written notice. | The Company also terminated a lease agreement during the fourth quarter of 2021 | |||||
Reduction of right-of-use operating lease assets | $ 100,000 | ||||||
Reduction of operating lease liabilities | $ 100,000 | ||||||
Operating lease, right-of -use asset | $ 100,000 | $ 100,000 | |||||
Operating Lease, Right-of-Use Asset, Statement of Financial Position [Extensible List] | Other non-current assets | Other non-current assets | |||||
Operating lease, liability | $ 110,000 | $ 110,000 | |||||
Operating lease, liability | 117,000 | 117,000 | |||||
Operating lease, liability, current portion | $ 60,000 | $ 60,000 | |||||
Operating Lease, Liability, Current, Statement of Financial Position [Extensible List] | Accrued expenses and other current liabilities | Accrued expenses and other current liabilities | |||||
Operating lease, liability, non-current portion | $ 50,000 | $ 50,000 | |||||
Operating Lease, Liability, Noncurrent, Statement of Financial Position [Extensible List] | Other long-term liabilities | Other long-term liabilities | |||||
Research and development expense for termination | $ 800,000 | ||||||
Estimated service fees and pass-through expenses | $ 33,600,000 | ||||||
Active Pharmaceutical Ingredients [Member] | |||||||
Commitments And Contingencies [Line Items] | |||||||
Agreement description | Under a manufacture and supply agreement with the active pharmaceutical ingredients (“API”) manufacturer for molgramostim, Savara must make certain payments to the API manufacturer upon achievement of the milestones outlined in the table set forth below. Additionally, upon first receipt of marketing approval by Savara from a regulatory authority in a country for a product containing the API for therapeutic use in humans and ending the earlier of (i) ten (10) years thereafter or (ii) the date a biosimilar of such product is first sold in such country, Savara shall pay the API manufacturer a royalty equal to low-single digits of the net sales in that country. | ||||||
Nebulizer [Member] | |||||||
Commitments And Contingencies [Line Items] | |||||||
Royalty percent on net sale | 3.50% | ||||||
TX Lease | |||||||
Commitments And Contingencies [Line Items] | |||||||
Lease term | 6 months | 6 months | |||||
Lease agreement date | Jun. 03, 2021 | ||||||
Lease commencement date | Aug. 01, 2021 | ||||||
Lease expiration date | Dec. 31, 2022 | ||||||
Operating lease, right-of -use asset | $ 0 | $ 0 | $ 100,000 | ||||
Operating lease, liability | $ 0 | $ 0 | $ 100,000 | ||||
PA Lease | |||||||
Commitments And Contingencies [Line Items] | |||||||
Lease commencement date | Oct. 01, 2021 | ||||||
Lease expiration date | Sep. 30, 2024 | ||||||
Operating lease, right-of -use asset | $ 200,000 | ||||||
Operating lease, liability | $ 200,000 | ||||||
CEO [Member] | |||||||
Commitments And Contingencies [Line Items] | |||||||
Employment agreement description | Upon (i) termination without cause, (ii) termination due to the CEO’s death or disability, or (iii) the CEO’s resignation for good reason, the CEO is entitled to receive (i) a lump sum payment equal to 18 months of base salary, (ii) a lump sum payment equal to 100% of his target bonus, (iii) a pro-rated portion of the unpaid target bonus, (iv) reimbursement for continued coverage under medical benefit plans for 18 months or until covered under a separate plan from another employer, and (v) the immediate and full vesting of outstanding non-vested Company equity awards. Additionally, all of the CEO’s outstanding stock options will be exercisable through the earlier of (x) the 18 month anniversary of the termination date or (y) the original expiration date. | ||||||
Percentage of target bonus to be paid upon termination | 100% | ||||||
CEO [Member] | Termination Other Than for Cause Death or Disability or Resignation for Good Reason [Member] | |||||||
Commitments And Contingencies [Line Items] | |||||||
Employment agreement description | Upon a termination other than for cause, death or disability or resignation for good reason within three months prior to or 12 months following a change in control, the CEO is entitled to receive (i) a lump sum payment of an amount equal to 24 months of base salary, plus 100% of the unpaid target bonus, plus a pro-rated portion of any unpaid bonus earned during the relevant performance period, (ii) reimbursement for continued coverage under medical benefit plans for 24 months or until covered under a separate plan from another employer, and (iii) the immediate and full vesting of outstanding non-vested Company equity awards. Additionally, all of the CEO’s outstanding stock options will be exercisable through the earlier of (x) the 24-month anniversary of the termination date or (y) the original expiration date. | ||||||
Chief Financial Officer (“CFO”) and Chief Medical Officer (“CMO”) [Member] | |||||||
Commitments And Contingencies [Line Items] | |||||||
Employment agreement description | Each of the Company’s Chief Financial Officer (“CFO”) and Chief Medical Officer (“CMO”) is entitled to payments and benefits if the CFO or CMO, respectively, is (i) terminated without cause, (ii) terminated due to the CFO or CMO's death or disability, or (iii) resigns for good reason, which includes (i) a lump sum payment equal to 12 months of base salary and a pro-rated portion of their unpaid bonus, (ii) reimbursement for continued coverage under medical benefit plans for 12 months or until covered under a separate plan from another employer, and (iii) accelerated vesting of outstanding non-vested Company equity awards equal to 12 months. Upon a termination other than for cause, death or disability or resignation for good reason within three months prior to or 12 months following a change in control, the CFO or CMO is entitled to receive (i) a lump sum payment of an amount equal to 18 months of base salary, plus 100% of their target bonus, plus a pro-rated portion of their unpaid target bonus, (ii) a lump sum payment equal to the amount required to continue coverage under medical benefit plans for 18 months, and (iii) the immediate and full vesting of outstanding non-vested options at the time of such termination. |
Commitments - Schedule of Matur
Commitments - Schedule of Maturity Analysis of Annual Undiscounted Cash Flows Reconciled to Carrying Value of Operating Lease Liabilities (Detail) $ in Thousands | Dec. 31, 2022 USD ($) |
Commitments and Contingencies Disclosure [Abstract] | |
2023 | $ 63 |
2024 | 54 |
Total future minimum lease payments | 117 |
Less imputed interest | (7) |
Operating lease, liability | $ 110 |
Commitments - Schedule of Lease
Commitments - Schedule of Lease Cost and Other Information (Detail) $ in Thousands | 12 Months Ended |
Dec. 31, 2022 USD ($) | |
Leases [Abstract] | |
Operating cash outflows from operating leases | $ 151 |
Weighted-average remaining lease term (in months) - operating leases | 21 months |
Weighted-average discount rate - operating leases | 7.80% |
Commitments - Schedule of Manuf
Commitments - Schedule of Manufacturing Commitments and Contingencies (Details) $ in Thousands | 12 Months Ended |
Dec. 31, 2022 USD ($) | |
Commitments And Contingencies [Line Items] | |
Total manufacturing and other commitments | $ 2,836 |
Active Pharmaceutical Ingredients [Member] | |
Commitments And Contingencies [Line Items] | |
Achievement of certain milestones related to validation of API and regulatory approval of molgramostim | 2,300 |
Molgramostim Nebulizer Manufacturer [Member] | |
Commitments And Contingencies [Line Items] | |
Achievement of various development activities and regulatory approval of nebulizer utilized to administer molgramostim | $ 536 |
Related Parties - Additional In
Related Parties - Additional Information (Detail) - shares | Mar. 15, 2021 | Dec. 31, 2022 |
Related Party Transaction [Line Items] | ||
Warrants issued | 38,808,502 | |
Public Offering [Member] | Bain [Member] | ||
Related Party Transaction [Line Items] | ||
Common stock, shares issued | 19,517,241 | |
Public Offering [Member] | Pre-Funded PIPE Warrants [Member] | Bain [Member] | ||
Related Party Transaction [Line Items] | ||
Warrants issued | 17,175,172 |
Stock-Based Compensation - Addi
Stock-Based Compensation - Additional Information (Detail) $ / shares in Units, $ in Millions | 12 Months Ended | |
Dec. 31, 2022 USD ($) $ / shares shares | Dec. 31, 2021 $ / shares shares | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Options granted to purchase common stock | 2,812,000 | |
Options exercised to purchase common stock | 2,344 | |
Non-Employees [Member] | ||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Options granted to purchase common stock | 0 | 0 |
Stock Options [Member] | ||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Dividend yield | 0% | |
Weighted-average grant date fair value | $ / shares | $ 1.13 | $ 0.88 |
Total compensation cost not yet recognized | $ | $ 4.7 | |
Weighted-average period to be recognized | 3 years 2 months 12 days | |
RSUs [Member] | ||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Total compensation cost not yet recognized | $ | $ 1.9 | |
Weighted-average period to be recognized | 1 year 8 months 12 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 | |
2015 Omnibus Incentive Option Plan [Member] | ||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Common stock available for grant | 1,891,422 | |
Purchase price of shares of common stock | less than 100% | |
Percentage of purchase price of shares of common stock | 100% | |
2015 Omnibus Incentive Option Plan [Member] | Stock Options [Member] | ||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Ratio of stock options or stock appreciation rights granted against shares available for issuance | 1 | |
2015 Omnibus Incentive Option Plan [Member] | Other Than Stock Option [Member] | ||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Ratio of stock options or stock appreciation rights granted against shares available for issuance | 1.34 | |
2008 Plan and 2015 Plan [Member] | Stock Options [Member] | ||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Contractual term | 10 years | |
Vesting period | 4 years | |
Vesting interval period | quarterly | |
2008 Plan and 2015 Plan [Member] | RSUs [Member] | ||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Vesting period | 4 years | |
Vesting interval period | quarterly | |
2008 Plan and 2015 Plan [Member] | RSUs [Member] | Cliff Vest [Member] | ||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Vesting period | 2 years | |
2021 Inducement Equity Incentive Plan [Member] | ||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Common stock available for grant | 1,197,500 | |
2021 Inducement Equity Incentive Plan [Member] | Stock Options [Member] | ||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Contractual term | 10 years | |
Vesting period | 4 years | |
Vesting interval period | quarterly | |
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 Assumptions Used for Estimating the Fair Value of Stock Options Granted to Employees (Detail) - Employees [Member] - 2015 Omnibus Incentive Option Plan [Member] | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Risk-free interest rate, Minimum | 2.11% | 0.77% |
Risk-free interest rate, Maximum | 3.94% | 1.27% |
Expected volatility, Minimum | 88.50% | 79.70% |
Expected volatility, Maximum | 97.44% | 91.20% |
Dividend yield | 0% | 0% |
Minimum [Member] | ||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Expected term (years) | 6 years 21 days | 6 years 21 days |
Maximum [Member] | ||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Expected term (years) | 6 years 25 days |
Stock-Based Compensation - Su_2
Stock-Based Compensation - Summary of Stock Option Activity and RSU Activity (Detail) - USD ($) $ / shares in Units, $ in Thousands | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Stock Options, Shares Underlying Option Awards, Outstanding at beginning balance | 6,218,841 | |
Stock Options, Shares Underlying Option Awards, Granted | 2,812,000 | |
Stock Options, Shares Underlying Option Awards, Exercised | (2,344) | |
Stock Options, Shares Underlying Option Awards, Expired/cancelled/forfeited | (1,095,313) | |
Stock Options, Shares Underlying Option Awards, Outstanding at ending balance | 7,933,184 | 6,218,841 |
Stock Options, Shares Underlying Option Awards, Options exercisable | 3,330,099 | |
Stock Options, Shares Underlying Option Awards, Vested and expected to vest | 7,933,184 | |
Stock Options, Weighted-Average Exercise Price, beginning balance | $ 2.25 | |
Stock Options, Weighted-Average Exercise Price, Granted | 1.48 | |
Stock Options, Weighted-Average Exercise Price, Exercised | 0.65 | |
Stock Options, Weighted-Average Exercise Price, Expired/cancelled/forfeited | 1.51 | |
Stock Options, Weighted-Average Exercise Price, ending balance | 2.08 | $ 2.25 |
Stock Options, Weighted-Average Exercise Price, Options exercisable | 3.01 | |
Stock Options, Weighted-Average Exercise Price, Vested and expected to vest | $ 2.08 | |
Stock Options, Weighted-Average Remaining Contractual Years | 8 years 4 months 24 days | 8 years 7 months 2 days |
Stock Options, Weighted-Average Remaining Contractual Years, Granted | 6 years 21 days | |
Stock Options, Weighted-Average Remaining Contractual Years, Options exercisable | 7 years 1 month 28 days | |
Stock Options, Weighted-Average Remaining Contractual Years, Vested and expected to vest | 8 years 4 months 24 days | |
Stock Options, Aggregate Intrinsic Value Outstanding | $ 1,440 | $ 354 |
Stock Options, Aggregate Intrinsic Value, Options exercised | 2 | |
Stock Options, Aggregate Intrinsic Value, Options exercisable | 676 | |
Stock Options, Aggregate Intrinsic Value, Vested and expected to vest | $ 1,440 | |
RSU's, Shares Underlying Option Awards, Beginning balance | 1,272,375 | |
RSUs, Shares Underlying Option Awards, Granted | 949,000 | |
RSUs, Shares Underlying Option Awards, Vested | (8,672) | |
RSUs, Shares Underlying Option Awards, Expired/cancelled/forfeited | (270,453) | |
RSU's, Shares Underlying Option Awards, Ending balance | 1,942,250 | 1,272,375 |
RSU's Weighted-Average Grant Date Fair Value, Beginning balance | $ 1.20 | |
RSU's Weighted-Average Grant Date Fair Value, Granted | 1.49 | |
RSU's Weighted-Average Grant Date Fair Value, Vested | 3.35 | |
RSU's Weighted-Average Grant Date Fair Value, Expired/cancelled/forfeited | 1.30 | |
RSU's Weighted-Average Grant Date Fair Value, Ending balance | $ 1.32 | $ 1.20 |
Stock-Based Compensation - Stoc
Stock-Based Compensation - Stock-based Compensation Expense included in Accompanying Statements of Operations and Comprehensive Loss (Detail) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Employee Service Share Based Compensation Allocation Of Recognized Period Costs [Line Items] | ||
Total stock-based compensation | $ 2,041 | $ 3,260 |
Research and Development [Member] | ||
Employee Service Share Based Compensation Allocation Of Recognized Period Costs [Line Items] | ||
Total stock-based compensation | 448 | 1,286 |
General and Administrative [Member] | ||
Employee Service Share Based Compensation Allocation Of Recognized Period Costs [Line Items] | ||
Total stock-based compensation | $ 1,593 | $ 1,974 |
Income Taxes - Components of Lo
Income Taxes - Components of Loss Before Income Taxes (Detail) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Income (Loss) from Continuing Operations before Income Taxes, Noncontrolling Interest [Abstract] | ||
Domestic | $ (29,326) | $ (28,705) |
Foreign | (8,824) | (14,309) |
Total | $ (38,150) | $ (43,014) |
Income Taxes - Additional Infor
Income Taxes - Additional Information (Detail) - USD ($) | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Operating Loss Carryforwards [Line Items] | ||
Federal tax benefit related to deferred tax liability | $ 0 | |
State provision for income taxes | 0 | $ 0 |
(Decrease) increase in valuation allowance | 3,100,000 | (10,900,000) |
Valuation allowance decrease due to Section 382 limited NOLs and credits | 25,249,000 | |
Valuation allowance offset amount | 13,200,000 | |
Foreign translation adjustments | $ 1,100,000 | |
Increase in shareholders ownership interest, percentage | 5% | |
Change in ownership interest, percentage points | 0.50% | |
Change in ownership interest period | 3 years | |
Research and orphan drug tax credit carry forwards | 5,966,000 | $ 4,351,000 |
Net operating loss carryforwards | 38,969,000 | 36,298,000 |
Foreign net operating loss carryforwards | 81,800,000 | 71,800,000 |
State net operating loss carryforwards | 3,500,000 | 3,500,000 |
Unrecognized tax benefits | 0 | 0 |
Interest and penalties related to income taxes | 0 | 0 |
Internal Revenue Service ("IRS") [Member] | ||
Operating Loss Carryforwards [Line Items] | ||
Net operating loss carryforwards | 47,400,000 | |
Research and orphan drug tax credit carry forwards | 15,300,000 | |
Federal [Member] | ||
Operating Loss Carryforwards [Line Items] | ||
Net operating loss carryforwards | 98,600,000 | 96,000,000 |
Research and orphan drug tax credit carry forwards | 5,200,000 | 3,600,000 |
Net operating loss carryforwards | $ 52,400,000 | 50,600,000 |
Tax credit carry forwards expiration beginning year | 2039 | |
Operating loss carry forwards expiration beginning Year | 2037 | |
Operating loss carry forwards with expiration date | $ 5,200,000 | |
Operating loss carry forwards with no expiration date | $ 93,400,000 | |
Federal [Member] | Internal Revenue Service ("IRS") [Member] | ||
Operating Loss Carryforwards [Line Items] | ||
Open tax year | 2018 | |
State and Local Jurisdiction [Member] | ||
Operating Loss Carryforwards [Line Items] | ||
Tax credit carry forwards expiration beginning year | 2034 | |
Operating loss carry forwards expiration beginning Year | 2038 | |
State research and development tax credit carryforwards | $ 500,000 | $ 600,000 |
State of Texas [Member] | Internal Revenue Service ("IRS") [Member] | ||
Operating Loss Carryforwards [Line Items] | ||
Open tax year | 2017 | |
Foreign Tax Authorities [Member] | Internal Revenue Service ("IRS") [Member] | ||
Operating Loss Carryforwards [Line Items] | ||
Open tax year | 2018 |
Income Taxes - Components of Be
Income Taxes - Components of Benefit for Income Taxes (Detail) - USD ($) | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Current: | ||
State | $ 0 | $ 0 |
Deferred: | ||
Federal | $ 0 |
Income Taxes - Reconciliation o
Income Taxes - Reconciliation of Expected Income Tax (Detail) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Income Tax Disclosure [Abstract] | ||
Income tax benefit computed at federal statutory tax rate | $ (8,011) | $ (9,033) |
Change in valuation allowance | 4,286 | (12,253) |
Orphan drug & research credits generated | (1,677) | (1,966) |
Impact of foreign operations | (16) | (177) |
Sec. 382 Limitation | 25,249 | |
Foreign deferred tax asset - true up | 2,021 | (3,833) |
Imputed interest | 1,006 | 1,253 |
Permanent differences | 2,213 | 738 |
Other | $ 178 | $ 22 |
Income Taxes - Significant Comp
Income Taxes - Significant Components of Deferred Tax Assets and Liabilities (Detail) - USD ($) $ in Thousands | Dec. 31, 2022 | Dec. 31, 2021 |
Deferred tax liabilities: | ||
Other | $ 329 | $ 574 |
Total deferred tax liabilities | 329 | 574 |
Deferred tax assets: | ||
Net operating loss carryforwards | 38,969 | 36,298 |
Intangible assets | 267 | 5,380 |
Amortization | 1,165 | 1,212 |
Credit carryforwards | 5,966 | 4,351 |
Section 174 research and development expenses | 3,663 | |
Accrued liabilities & other | 1,203 | 1,107 |
Total deferred tax assets | 51,233 | 48,348 |
Subtotal | 50,904 | 47,774 |
Valuation allowance | $ (50,904) | $ (47,774) |
Net Loss Per Share - Schedule o
Net Loss Per Share - Schedule of Potentially Dilutive Securities (Detail) - shares | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Earnings Per Share Basic [Line Items] | ||
Potentially dilutive securities | 9,953,227 | 7,569,009 |
Awards under Equity Incentive Plan [Member] | ||
Earnings Per Share Basic [Line Items] | ||
Potentially dilutive securities | 7,933,184 | 6,218,841 |
Nonvested Restricted Shares and Restricted Stock Units [Member] | ||
Earnings Per Share Basic [Line Items] | ||
Potentially dilutive securities | 1,942,250 | 1,272,375 |
Warrants to Purchase Common Stock [Member] | ||
Earnings Per Share Basic [Line Items] | ||
Potentially dilutive securities | 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 | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Earnings Per Share [Abstract] | ||
Net loss | $ (38,150) | $ (43,014) |
Net loss attributable to common stockholders | (38,150) | (43,014) |
Undistributed earnings and net loss attributable to common stockholders, basic and diluted | $ (38,150) | $ (43,014) |
Weighted Average Number of Shares Outstanding, Basic | 152,771,817 | 133,919,145 |
Weighted Average Number of Shares Outstanding, Diluted | 152,771,817 | 133,919,145 |
Earnings Per Share, Basic | $ (0.25) | $ (0.32) |
Earnings Per Share, Diluted | $ (0.25) | $ (0.32) |
Subsequent Events (Additional I
Subsequent Events (Additional Information) (Details) - Subsequent Event [Member] $ in Thousands | Mar. 10, 2023 USD ($) | Feb. 28, 2023 ft² |
Silicon Valley Bank [Member] | Maximum [Member] | ||
Subsequent Event [Line Items] | ||
Deposits insured by FDIC limit | $ | $ 250 | |
PA Lease | ||
Subsequent Event [Line Items] | ||
Number of additional square feet leased | 3,970 | |
Number of square feets leased | 6,435 |