Savara Inc. 2025年季度报告

Table of Contents PART I.FINANCIAL INFORMATION Item 1.Financial Statements (Unaudited)Condensed Consolidated Balance SheetsCondensed Consolidated Statements of Operations and Comprehensive LossConsolidated Statements of Changes in Stockholders’ EquityCondensed Consolidated Statements of Cash FlowsNotes to Condensed Consolidated Financial StatementsItem 2.Management’s Discussion and Analysis of Financial Condition and Results of OperationsItem 3.Quantitative and Qualitative Disclosures About Market RiskItem 4.Controls and ProceduresPART II.OTHER INFORMATIONItem 1.Legal ProceedingsItem 1A.Risk FactorsItem 2.Unregistered Shares of Equity Securities and Use of ProceedsItem 3.Defaults Upon Senior SecuritiesItem 4.Mine Safety DisclosuresItem 5.Other InformationItem 6.ExhibitsExhibit IndexSignatures Savara Inc. and SubsidiariesCondensed Consolidated Statements ofOperations and Comprehensive Loss(In thousands, except share and per share amounts) Savara Inc. and SubsidiariesCondensed Consolidated Statements of Changes in Stockholders’ Equity (continued)Periods Ended March 31, 2025 and 2024 Savara Inc. and SubsidiariesCondensed Consolidated Statements of Cash Flows(In thousands) Savara Inc. and SubsidiariesNotes to Condensed Consolidated Financial Statements (Unaudited) 1. Organization and Nature of Operations Description of Business Savara Inc. (together with its subsidiaries “Savara,” the “Company,” “we” or “us”) is a clinical-stage biopharmaceuticalcompany focused on rare respiratory diseases. The Company’s sole program, molgramostim inhalation solution("MOLBREEVI" or "molgramostim"), is an investigational inhaled biologic, specifically an inhaled granulocyte-macrophage colony-stimulating factor ("GM-CSF") in Phase 3 development for autoimmune pulmonary alveolar Since inception, Savara has devoted its efforts and resources to identifying and developing its product candidates,recruiting personnel, and raising capital. Savara has incurred operating losses and negative cash flow from operationsand hasnoproduct revenue from inception to date. The Company has not yet commenced commercial operations. 2. Summary of Significant Accounting Policies Basis of Presentation The unaudited interim condensed consolidated financial statements have been prepared in conformity with accountingprinciples generally accepted in the United States (“U.S. GAAP”) as defined by the Financial Accounting StandardsBoard (“FASB”). The unaudited condensed consolidated financial statements have been prepared on the same basisas the annual consolidated financial statements and reflect, in the opinion of management, all adjustments that are Certain information and footnote disclosures normally included in annual financial statements prepared in accordancewith U.S. GAAP have been omitted from these condensed consolidated financial statements, as permitted by rules andregulations of the U.S. Securities and Exchange Commission (the “SEC”). The Company believes the disclosuresmade in these condensed consolidated financial statements are adequate to make the information herein notmisleading. The Company recommends that these condensed consolidated financial statements be read in conjunction Principles of Consolidation The interim condensed consolidated financial statements of the Company are stated in U.S. dollars and are preparedunder U.S. GAAP. These condensed consolidated financial statements include the accounts of the Company and itswholly-owned subsidiaries. The financial statements of the Company’s wholly-owned subsidiaries are recorded in theirfunctional currency and translated into the reporting currency. The cumulative effect of changes in exchange ratesbetween the foreign entity’s functional currency and the reporting currency is reported inAccumulated other Liquidity As of March 31, 2025, the Company had an accumulated deficit of approximately$515.9million, cash and cashequivalents of$19.6millionand short-term investments of$152.9million. The Company used cash in operatingactivities of approximately$27.2millionduring the three months ended March 31, 2025. The cost to further developand obtain regulatory approval for any drug is substantial and, as noted below, the Company may have to take certain The Company is currently focused on the development of MOLBREEVI for the treatment of aPAP and believes suchactivities will result in the continued incurrence of significant research and development and other expenses related tothis program. If the Company’s product candidate does not gain regulatory approval or, if approved, fails to achieve acceptance, the Company may never become profitable. Even if the Company achieves profitability in the future, it maynot be able to sustain profitability in subsequent periods. The Company intends to cover its future operating expensesthrough cash and cash equivalents on hand, short-term investments, and through a combination of equity offerings, The Company’s cash and cash equivalents of$19