Savara Inc 10-K

Item 9A. Controls and Procedures. Evaluation of Disclosure Controls and Procedures Our management has evaluated, under the supervision and with the participation of our Chief Executive Officer and Chief Financial & Administrative Officer, the effectiveness of our disclosure controls and procedures as of December 31, 2024, pursuant to and as required by Rule 13a-15(b) under the Exchange Act. Based on that evaluation, our Chief Executive Officer and Chief Financial & Administrative Officer have concluded that, as of December 31, 2024, our disclosure controls and procedures, as defined by Rule 13a-15(e) under the Exchange Act, were effective and designed to ensure that (i) information required to be disclosed in our reports filed or submitted under the Exchange Act is recorded, processed, summarized, and reported within the time periods specified in the SEC's rules and forms and (ii) information is accumulated and communicated to management, including the Chief Executive Officer and Chief Financial & Administrative Officer, as appropriate, to allow timely decisions regarding required disclosures. Management's Report on Internal Control Over Financial Reporting Our management is responsible for establishing and maintaining adequate internal control over financial reporting, as such term is defined in Exchange Act Rule 13a-15(f). Under the supervision and with the participation of our management, including our Chief Executive Officer and Chief Financial & Administrative Officer, we assessed the effectiveness of our internal control over financial reporting based on the framework in Internal Control - Integrated Framework (2013) issued by the Committee of Sponsoring Organizations of the Treadway Commission (“COSO”). As a result of that assessment, management concluded that our internal control over financial reporting was effective as of December 31, 2024 based on criteria in Internal Control - Integrated Framework (2013) issued by the COSO. As a smaller reporting company, we were not required to obtain an audit on the effectiveness of our internal control over financial reporting as of December 31, 2024. Changes in Internal Control Over Financial Reporting There were no changes in our internal control over financial reporting that occurred during Savara’s quarter ended December 31, 2024 that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting. Item 9B. Other Information: Rule 10b5-1 Trading Plans Our policy governing transactions in our securities by our directors, officers and employees permits our directors, officers and employees to enter into trading plans complying with Rule 10b5-1 under the Exchange Act. The following table describes the written plans for the sale of our securities terminated by our executive officers and directors during the quarter ended December 31, 2024, each of which was entered into and terminated during an open trading window and was intended to satisfy the affirmative defense conditions of Rule 10b5-1(c) (each, a Trading Plan). Name and Title Date of Adoption of Trading Plan Scheduled Start Date of Trading Plan Scheduled Expiration Date of Trading Plan Maximum Shares Subject to Trading Plan Date Plan Terminated (1) Matthew Pauls Chief Executive Officer and Chair of the Board of Directors 9/25/2024 12/26/2024 5/15/2025 150,000 12/2/2024 David Lowrance Chief Financial and Administrative Officer 9/24/2024 12/26/2024 5/15/2025 85,000 12/2/2024 (1) Each Trading Plan was terminated prior to any sales being made pursuant to such Trading Plan. No other Company directors or officers (as defined in Rule 16a-1(f) under the Exchange Act) adopted , modified or terminated a Rule 10b5-1 trading arrangement or a non-Rule 10b5-1 trading arrangement (as defined in Item 408(c) of Regulation S-K) during the quarter ended December 31, 2024. Item 9C. Disclosure Regarding Foreign Jurisdictions that Prevent Inspections. Not applicable 58 PART III Certain information required by Part III of this report is omitted from this report pursuant to General Instruction G(3) of Form 10-K because we will file a definitive proxy statement pursuant to Regulation 14A for our 2024 annual meeting of stockholders (the “Proxy Statement”) not later than 120 days after the end of the fiscal year covered by this report, and the information included in the Proxy Statement that is required by Part III of this report is incorporated herein by reference. Item 10. Directors, Executive Off icers, and Corporate Governance. Code of Ethics We have adopted a code of ethics that applies to our principal executive officer, principal financial officer, principal accounting officer, or persons performing similar functions, as well as all of our other officers, directors, and employees. This code of ethics is a part of our code of business conduct and ethics, and is available on our corporate website at http://www.savarapharma.com. We intend to disclose future amendments to, or waivers of, certain provisions of our code of ethics that apply to our principal executive officer, principal financial officer, principal accounting officer, or persons performing similar functions on our corporate website within four business days following such amendment or waiver. The other information required by this item will be set forth in the Proxy Statement and is incorporated into this report by reference. Item 11. Executiv e Compensation. The information required by this item will be set forth in the Proxy Statement and is incorporated into this report by reference. Item 12. Security Ownership of Certain Beneficial Own ers and Management and Related Stockholder Matters. The other information required by this item will be set forth in the Proxy Statement and is incorporated into this report by reference. Equity Compensation Plan Information The table below provides information about our common stock that, as of December 31, 2024, may be issued upon the exercise of options and the vesting of RSUs under the following equity compensation plans (which are all our equity compensation plans; provided, however, that new equity awards may only be issued under the 2024 Omnibus Incentive Plan and the 2021 Inducement Plan): • 2024 Omnibus Incentive Plan (the “2024 Plan”) • Savara Inc. Stock Option Plan (the “2008 Plan”) • 2021 Inducement Equity Incentive Plan (the "2021 Inducement Plan”) Plan Category Number of securities to be issued upon exercise of outstanding options, warrants and rights Weighted-average exercise price of outstanding options, warrants and rights (1) Number of securities remaining available for future issuance under equity compensation plans (excluding securities reflected in column (a)) (a) (b) (c) Equity compensation plans approved by security holders 14,656,246 $ 2.86 7,153,602 Equity compensation plans not approved by security holders 3,575,875 $ 2.50 1,272,799 Total (2),(3) 18,232,121 $ 2.79 8,426,401 (1) The weighted average exercise price does not take into account the shares issuable upon vesting of outstanding RSUs, which have no exercise price. 59 (2) Includes 10,766,914 shares issuable upon the exercise of outstanding options granted under the 2024 Plan, 2,648,375 shares issuable upon the exercise of outstanding options granted under the 2021 Inducement Plan, and 139,332 shares issuable upon the exercise of outstanding options granted under the 2008 Plan. (3) Includes 3,750,000 shares issuable upon the vesting of RSUs granted under the 2024 Plan and 927,500 shares issuable upon the vesting of RSUs granted under the 2021 Inducement Plan. Item 13. Certain Relationships and Related Transactions, and Director Independence. The information required by this item will be set forth in the Proxy Statement and is incorporated into this report by reference. Item 14. Principal Accoun ting Fees and Services. The information required by this item will be set forth in the Proxy Statement and is incorporated into this report by reference. 60 PART IV Item 15. Exhibits, Financ ial Statement Schedules. (a) Documents Filed . The following documents are filed as part of this report: (1) Financial Statements. The following report of RSM US LLP and financial statements: • Report of Independent Registered Public Accounting Firm • Consolidated Balance Sheets as of December 31, 2024 and 2023 • Consolidated Statements of Operations and Comprehensive Loss for the years ended December 31, 2024 and 2023 • Consolidated Statements of Changes in Stockholders’ Equity for the years ended December 31, 2024 and 2023 • Consolidated Statements of Cash Flows for the years ended December 31, 2024 and 2023 • Notes to Consolidated Financial Statements (1) Financial Statement Schedules. See subsection (c) below. (2) Exhibits. See subsection (b) below. (b) Exhibits. The exhibits filed or furnished with this report are set forth on the Exhibit Index immediately following the signature page of this report, which Exhibit Index is incorporated herein by reference. (c) Financial Statement Schedules . All schedules are omitted because they are not applicable or the required information is shown in the financial statements or notes thereto. Item 16. Form 10-K Summary. Not applicable. 61 Exhibit Index Exhibit Number Description 3.1 Savara Inc. Certificate of Amendment to Amended and Restated Certificate of Incorporation (Incorporated by reference to Exhibit 3.1 to the Registrant’s Current Report on Form 8-K filed on June 7, 2024). 3.2 Amended and Restated Bylaws of Savara, Inc., dated March 28, 2023 (Incorporated by reference to Exhibit 3.1 to the Registrant’s Current Report on Form 8-K filed on March 30, 2023). 4.1 Form of common stock certificate of the Registrant (Incorporated by reference to Exhibit 4.1 to the Registrant’s Annual Report on Form 10-K filed on March 14, 2018.) 4.2 Warrant to Purchase Shares of Common Stock of the Registrant issued to Life Science Loans II, LLC on April 28, 2017 (Incorporated by reference to Exhibit 4.3 to the Registrant’s Quarterly Report on Form 10-Q filed on May 9, 2017.) 4.3 Warrant to Purchase Shares of Common Stock of the Registrant issued to Silicon Valley Bank on April 28, 2017 (Incorporated by reference to Exhibit 4.2 to the Registrant’s Quarterly Report on Form 10-Q filed on May 9, 2017.) 4.4 Amendment to Warrant to Purchase Shares of Common Stock of the Registrant issued to Life Science Loans II, LLC on June 26, 2017. (Incorporated by reference to Exhibit 4.1 to the Registrant’s Quarterly Report on Form 10-Q filed on August 9, 2017.) 4.5 Amendment to Warrant to Purchase Shares of Common Stock of the Registrant issued to SVB Financial Group on June 26, 2017. (Incorporated by reference to Exhibit 4.2 to the Registrant’s Quarterly Report on Form 10-Q filed on August 9, 2017.) 4.6 Warrant to Purchase Shares of Common Stock of the Registrant issued to Life Science Loans II, LLC on June 26, 2017. (Incorporated by reference to Exhibit 4.3 to the Registrant’s Quarterly Report on Form 10-Q filed on August 9, 2017.) 4.7 Warrant to Purchase Shares of Common Stock of the Registrant issued to Silicon Valley Bank on June 26, 2017. (Incorporated by reference to Exhibit 4.4 to the Registrant’s Quarterly Report on Form 10-Q filed on August 9, 2017.) 4.8 Form of Pre-Funded Warrant (Incorporated by reference to Exhibit 4.1 to the Registrant’s Current Report on Form 8-K filed on October 25, 2017.) 4.9 Warrant to Purchase Shares of Common Stock of the Registrant issued to Life Science Loans II, LLC on December 4, 2018. (Incorporated by reference to Exhibit 4.19 to the Registrant’s Annual Report on Form 10-K filed on March 13, 2019.) 4.10 Warrant to Purchase Shares of Common Stock of the Registrant issued to Silicon Valley Bank on December 4, 2018. (Incorporated by reference to Exhibit 4.20 to the Registrant’s Annual Report on Form 10-K filed on March 13, 2019.) 4.11 Form of Common Stock Purchase Warrant (Incorporated by reference to Exhibit 4.1 to the Registrant’s Current Report on Form 8-K filed on December 20, 2019.) 4.12 Form of Pre-Funded Common Stock Purchase Warrant (Incorporated by reference to Exhibit 4.2 to the Registrant’s Current Report on Form 8-K filed on December 20, 2019.) 4.13 Second Amendment to Warrant to Purchase Common Stock dated January 31, 2020, to Warrant to Purchase Common Stock of the Registrant issued to Life Science Loans II, LLC on April 28, 2017 (as amended by that certain Amendment to Warrant to Purchase Common Stock dated as of June 26, 2017) (Incorporated by reference to Exhibit 4.1 to the Registrant’s Current Report on Form 8-K filed on February 3, 2020.) 4.14 Second Amendment to Warrant to Purchase Common Stock dated January 31, 2020, to Warrant to Purchase Common Stock of the Registrant issued to Silicon Valley Bank on April 28, 2017 (as amended by that certain Amendment to Warrant to Purchase Common Stock dated as of June 26, 2017) (Incorporated by reference to Exhibit 4.2 to the Registrant’s Current Report on Form 8-K filed on February 3, 2020.) 4.15 Amendment to Warrant to Purchase Common Stock of the Registrant dated January 31, 2020, to Warrant to Purchase Common Stock of the Registrant issued to Life Science Loans II, LLC on June 26, 2017 (Incorporated by reference to Exhibit 4.3 to the Registrant’s Current Report on Form 8-K filed on February 3, 2020.) 4.16 Amendment to Warrant to Purchase Common Stock of the Registrant dated January 31, 2020, to Warrant to Purchase Common Stock of the Registrant issued to Silicon Valley Bank on June 26, 2017 (Incorporated by reference to Exhibit 4.4 to the Registrant’s Current Report on Form 8-K filed on February 3, 2020.) 62 4.17 Amendment to Warrant to Purchase Common Stock of the Registrant dated January 31, 2020, to Warrant to Purchase Common Stock of the Registrant issued to Life Science Loans II, LLC on December 4, 2018 (Incorporated by reference to Exhibit 4.5 to the Registrant’s Current Report on Form 8-K filed on February 3, 2020.) 4.18 Amendment to Warrant to Purchase Common Stock of the Registrant dated January 31, 2020, to Warrant to Purchase Common Stock of the Registrant issued to Silicon Valley Bank on December 4, 2018 (Incorporated by reference to Exhibit 4.6 to the Registrant’s Current Report on Form 8-K filed on February 3, 2020.) 4.19 Description of Registered Securities (Incorporated by reference to Exhibit 4.25 to the Registrant’s Annual Report on Form 10-K filed on March 12, 2020.) 4.20 Form of Pre-Funded Warrant (Incorporated by reference to Exhibit 4.1 to the Registrant’s Current Report on Form 8-K filed on March 11, 2021.) 4.21 Form of Pre-Funded Warrant (Incorporated by reference to Exhibit 4.1 to the Registrant’s Current Report on Form 8-K filed on July 13, 2023). 10.1 Amended and Restated Loan and Security Agreement, dated April 21, 2022, between the Registrant and its subsidiary, Aravas Inc., as borrowers, and Silicon Valley Bank (Incorporated by reference to Exhibit 10.1 to the Registrant's Quarterly Report on Form 10-Q filed on May 11, 2022.) 10.2 # Savara Inc. Amended and Restated 2015 Omnibus Incentive Plan, as amended (Incorporated by reference to Appendix A of the Registrant’s Proxy Statement filed on April 19, 2022.) 10.3 # Form of Non-Statutory Stock Option Grant Agreement – Director (for grants to non-employee directors) under the 2015 Omnibus Incentive Plan (Incorporated by reference to Exhibit 10.2 to the Registrant’s Current Report on Form 8-K filed on June 16, 2015.) 10.4 # Form of Incentive Stock Option Grant Agreement – Exempt Employees under the 2015 Omnibus Incentive Plan (Incorporated by reference to Exhibit 10.3 to the Registrant’s Current Report on Form 8-K filed on June 16, 2015.) 10.5 # Form of Incentive Stock Option Grant Agreement – Non-Exempt Employees under the 2015 Omnibus Incentive Plan (Incorporated by reference to Exhibit 10.4 to the Registrant’s Current Report on Form 8-K filed on June 16, 2015.) 10.6 # Form of Non-Statutory Stock Option Grant Agreement – General under the 2015 Omnibus Incentive Plan (Incorporated by reference to Exhibit 10.8 to the Registrant’s Annual Report on Form 10-K filed on March 14, 2018.) 10.7 # Form of Grant of Restricted Stock Units under the 2015 Omnibus Incentive Plan. (Incorporated by reference to Exhibit 10.3 to the Registrant’s Quarterly Report on Form 10-Q filed on November 8, 2017.) 10.8 # Aravas Inc. (formerly Savara Inc.) Stock Option Plan (Incorporated by reference to Exhibit 10.53 to the Registrant’s Registration Statement on Form S-4 filed on February 10, 2017.) 10.9 # Aravas Inc. (formerly Savara Inc.) Form of Incentive Stock Option Agreement (Incorporated by reference to Exhibit 10.54 to the Registrant’s Registration Statement on Form S-4 filed on February 10, 2017.) 10.10 Savara Inc. 2021 Inducement Equity Incentive Plan (Incorporated by reference to Exhibit 4.1 to the Registrant's Registration Statement on Form S-8 filed on January 20 2023.) 10.11 Form of Non-Statutory Stock Option Agreement – Under the 2021 Inducement Equity Incentive Plan (Incorporated by reference to Exhibit 10.16 to the Registrant’s Annual Report on Form 10-K filed on March 30, 2022.) 10.12 Form of Restricted Stock Unit Agreement (Inducement Award) – Under the 2021 Inducement Equity Incentive Plan (Incorporated by reference to Exhibit 10.17 to the Registrant’s Annual Report on Form 10-K filed on March 30, 2022.) 10.13 # Form of Director and Officer Indemnification Agreement (Incorporated by reference to Exhibit 10.2 to the Registrant’s Current Report on Form 8-K filed on October 23, 2006.) 10.14 + Commercial Supply Agreement dated April 24, 2015 between PARI Pharma GmbH and Serendex Pharmaceuticals A/S (Incorporated by reference to Exhibit 10.62 to the Registrant’s Registration Statement on Form S-4 filed on February 10, 2017.) 10.15 + Research Collaboration and License Agreement dated November 7, 2014 between PARI Pharma GmbH and Serendex Pharmaceuticals A/S (Incorporated by reference to Exhibit 10.63 to the Registrant’s Registration Statement on Form S-4 filed on February 10, 2017.) 1016 + Amendment No. 1, effective May 23, 2018, to the Research Collaboration and License Agreement between Savara Inc. (as successor in interest to Serendex Pharmaceuticals A/S) and PARI Pharma GmbH dated November 7, 2014 (Incorporated by reference to Exhibit 10.3 of the Registrant’s Quarterly Report on Form 10-Q filed on August 9, 2018.) 10.17 Securities Purchase Agreement (Incorporated by reference to Exhibit 10.1 to the Registrant’s Current Report on Form 8-K filed on December 20, 2019.) 63 10.18 Registration Rights Agreement (Incorporated by reference to Exhibit 10.2 to the Registrant’s Current Report on Form 8-K filed on December 20, 2019.) 10.19 + Manufacture and Supply Agreement, dated as of April 26, 2019, between Savara ApS and GEMABIOTECH SAU (Incorporated by reference to Exhibit 10.1 of the Registrant’s Quarterly Report on Form 10-Q filed on May 9, 2019.) 10.20 + Master Services Agreement by and between Savara Inc. and Parexel International (IRL) Limited, effective January 6, 2021 (Incorporated by reference to Exhibit 10.4 of the Registrant's Quarterly Report on Form 10-Q filed on May 13, 2021.) 10.21 + Work Order under Master Services Agreement by and between Savara Inc. and Parexel International (IRL) Limited, effective January 6, 2021 (Incorporated by reference to Exhibit 10.5 of the Registrant's Quarterly Report on Form 10-Q filed on May 13, 2021.) 10.22 Sales Agreement, dated July 6, 2021, between the Registrant and Evercore Group L.L.C. (Incorporated by reference to Exhibit 1.2 of the Registrant’s Registration Statement on Form S-3 filed on July 6, 2021.) 10.23 Amended and Restated Executive Employment Agreement, dated December 13, 2022, between Savara Inc. and Matthew Pauls (Incorporated by reference to Exhibit 10.1 to the Registrant’s Current Report on Form 8-K filed on December 15, 2022.) 10.24 Amended and Restated Executive Employment Agreement, dated December 13, 2022, between Savara Inc. and David Lowrance (Incorporated by reference to Exhibit 10.2 to the Registrant’s Current Report on Form 8-K filed on December 15, 2022.) 10.25 + Amendment No. 1 to the Manufacture and Supply Agreement, dated December 7, 2022 entered into by and between Savara ApS and GEMABIOTECH SAU (Incorporated by reference to Exhibit 10.33 to the Registrant’s Annual Report on Form 10-K filed on March 30, 2023.) 10.26 Executive Employment Agreement, dated November 10, 2022, between Savara Inc. and Raymond D. Pratt, M.D. (Incorporated by reference to Exhibit 10.34 to the Registrant’s Annual Report on Form 10-K filed on March 30, 2023.) 10.27 Executive Employment Agreement, dated February 13, 2023, between Savara Inc. and Rob Lutz (Incorporated by reference to Exhibit 10.1 to the Registrant’s Current Report on Form 8-K filed on February 13, 2023.) 10.28 Lease Agreement, dated July 7, 2021, between Savara Inc. and 1717 OSSRE, LLC. (Incorporated by reference to Exhibit 10.1 of the Registrant's Quarterly Report on Form 10-Q filed on May 15, 2023.) 10.29 First Amendment to Lease Agreement, dated February 28, 2023, between Savara Inc. and 1717 OSSRE, LLC. (Incorporated by reference to Exhibit 10.1 of the Registrant's Quarterly Report on Form 10-Q filed on May 15, 2023.) 10.30 + Amendment No. 2 to the Manufacture and Supply Agreement, dated December 13, 2023 entered into by and between Savara ApS GEMABIOTECH SAU (Incorporated by reference to Exhibit 10.36 to the Registrant’s Annual Report on Form 10-K filed on March 7, 2024.) 64 10.31 + Master Services Agreement, dated February 13, 2024, by and between Fujifilm Diosynth Biotechnologies UK Limited, Fujifilm Diosynth Biotechnologies Texas, LLC, and Fujifilm Diosynth Biotechnologies U.S.A., Inc. and Savara Inc. (Incorporated by reference to Exhibit 10.1 of the Registrant's Quarterly Report on Form 10-Q filed on May 9, 2024.) 10.32 Savara Inc. 2021 Inducement Equity Incentive Plan, as amended (Incorporated by reference to Exhibit 4.1 to the Registrant’s Registration Statement on Form S-8 filed on March 7, 2024). 10.33 Savara Inc. 2024 Omnibus Incentive Plan (Incorporated by reference to Exhibit 10.1 to the Registrant’s Current Report on Form 8-K/A (Amendment No. 1) filed on June 10, 2024). 10.34 Savara Inc. 2021 Inducement Equity Incentive Plan, as amended (Incorporated by reference to Exhibit 4.1 to the Registrant’s Registration Statement on Form S-8 filed on October 1, 2024). 10.35 # Form of Incentive Stock Option Award Agreement under the 2024 Omnibus Incentive Plan. (Incorporated by reference to Exhibit 10.2 of the Registrant's Quarterly Report on Form 10-Q filed on November 12, 2024.) 10.36 # Form of Nonqualified Stock Option Award Agreement under the 2024 Omnibus Incentive Plan. (Incorporated by reference to Exhibit 10.3 of the Registrant's Quarterly Report on Form 10-Q filed on November 12, 2024.) 10.37 # Form of Restricted Stock Unit Award Agreement under the 2024 Omnibus Incentive Plan. (Incorporated by reference to Exhibit 10.4 of the Registrant's Quarterly Report on Form 10-Q filed on November 12, 2024.) 10.38 Executive Employment Agreement, dated October 15, 2024, between Savara Inc. and Braden Parker. 10.39 Executive Employment Agreement, dated August 24, 2023, between Savara Inc. and Anne Erickson. 10.40 Amended and Restated Executive Employment Agreement, dated March 13, 2025, between Savara Inc. and Kathleen McCabe. 10.41 + Master Services Agreement by and between Savara ApS and Selvita S.A., effective January 17, 2024. 21.1 List of Subsidiaries (Incorporated by reference to Exhibit 21.1 to the Registrant’s Annual Report on Form 10-K filed on March 30, 2023. ) 23.1 Consent of RSM US LLP, Independent Registered Public Accounting Firm 24.1 Power of Attorney included on page 66 of this Form 10-K 31.1 Certification of principal executive officer pursuant to Rule 13a-14(a)/15d-14(a) 31.2 Certification of principal financial officer pursuant to Rule 13a-14(a)/15d-14(a) 32.1 ** Certification of principal executive officer and principal financial officer pursuant to 18 U.S.C. 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 97 Clawback Policy 101.INS Inline XBRL Instance Document – the instance document does not appear in the Interactive Data File because XBRL tags are embedded within the Inline XBRL document. 101.SCH Inline XBRL Taxonomy Extension Schema With Embedded Linkbase Documents 104 Cover Page Interactive Data File (embedded within the Inline XBRL document) # Indicates management contract or compensatory plan + Indicates confidential treatment has been granted to certain portions of this exhibit, which portions have been omitted and filed separately with the SEC. ** These certifications are being furnished solely to accompany this report pursuant to 18 U.S.C. 1350, and are not being filed for purposes of Section 18 of the Securities Exchange Act of 1934 and are not to be incorporated by reference into any filing of the registrant, whether made before or after the date hereof, regardless of any general incorporation by reference language in such filing. 65 SIGNAT URES Pursuant to the requirements of Section 13 or 15(d) of the Securities Exchange Act of 1934, as amended, the Registrant has duly caused this Report to be signed on its behalf by the undersigned, thereunto duly authorized . Savara Inc. Date: March 27, 2025 By: /s/ Matthew Pauls Matthew Pauls Chief Executive Officer and Chair of the Board of Directors POWER OF ATTORNEY KNOW ALL PERSONS BY THESE PRESENTS, that each person whose signature appears below hereby constitutes and appoints Matthew Pauls and Dave Lowrance, and each of them acting individually, as his or her attorney-in-fact, each with full power of substitution, for him or her in any and all capacities, to sign any and all amendments to this Report on Form 10-K, and to file the same, with exhibits thereto and other documents in connection therewith, with the Securities and Exchange Commission, hereby ratifying and confirming our signatures as they may be signed by our said attorney to any and all amendments to said Report. Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, this Report has been signed below by the following persons on behalf of the Registrant in the capacities and on the dates indicated. Name Title Date /s/ Matthew Pauls Chief Executive Officer and Chair of the Board of Directors (Principal Executive Officer) March 27, 2025 Matthew Pauls /s/ Dave Lowrance Chief Financial and Administrative Officer (Principal Financial and Accounting Officer) March 27, 2025 Dave Lowrance /s/ David Ramsay Director March 27, 2025 David Ramsay /s/ Joseph McCracken Director March 27, 2025 Joseph McCracken /s/ Nevan Elam Director March 27, 2025 Nevan Elam /s/ Rick Hawkins Director March 27, 2025 Rick Hawkins /s/ An Van Es-Johansson Director March 27, 2025 An Van Es-Johansson 66 INDEX TO CONSOLIDATED FINANCIAL STATEMENTS Report of Independent Registered Public Accounting Firm (PCAOB ID: 49 ) F- 2 Consolidated Balance Sheets as of December 31, 2024 and 2023 F- 4 Consolidated Statements of Operations and Comprehensive Loss for the years ended December 31, 2024 and 2023 F- 5 Consolidated Statements of Changes in Stockholders’ Equity for the years ended December 31, 2024 and 2023 F- 6 Consolidated Statements of Cash Flows for the years ended December 31, 2024 and 2023 F- 7 Notes to Consolidated Financial Statements F- 8 F- 1 Report of Inde pendent Registered Public Accounting Firm To the Stockholders and the Board of Directors of Savara Inc. Opinion on the Financial Statements We have audited the accompanying consolidated balance sheets of Savara Inc. and its subsidiaries (the Company) as of December 31, 2024 and 2023, the related consolidated statements of operations and comprehensive loss, changes in stockholders’ equity, and cash flows for the years then ended, and the related notes to the consolidated financial statements (collectively, the financial statements). In our opinion, the financial statements present fairly, in all material respects, the financial position of the Company as of December 31, 2024 and 2023, and the results of its operations and its cash flows for the years then ended, in conformity with accounting principles generally accepted in the United States of America. Basis for Opinion These financial statements are the responsibility of the Company’s management. Our responsibility is to express an opinion on the Company’s financial statements based on our audits. We are a public accounting firm registered with the Public Company Accounting Oversight Board (United States) (PCAOB) and are required to be independent with respect to the Company in accordance with U.S. federal securities laws and the applicable rules and regulations of the Securities and Exchange Commission and the PCAOB. We conducted our audits in accordance with the standards of the PCAOB. Those standards require that we plan and perform the audit to obtain reasonable assurance about whether the financial statements are free of material misstatement, whether due to error or fraud. The Company is not required to have, nor were we engaged to perform, an audit of its internal control over financial reporting. As part of our audits we are required to obtain an understanding of internal control over financial reporting but not for the purpose of expressing an opinion on the effectiveness of the Company’s internal control over financial reporting. Accordingly, we express no such opinion. Our audits included performing procedures to assess the risks of material misstatement of the financial statements, whether due to error or fraud, and performing procedures that respond to those risks. Such procedures included examining, on a test basis, evidence regarding the amounts and disclosures in the financial statements. Our audits also included evaluating the accounting principles used and significant estimates made by management, as well as evaluating the overall presentation of the financial statements. We believe that our audits provide a reasonable basis for our opinion. Critical Audit Matter The critical audit matter communicated below is a matter arising from the current period audit of the financial statements that was communicated or required to be communicated to the audit committee and that: (1) relates to accounts or disclosures that are material to the financial statements and (2) involved our especially challenging, subjective or complex judgments. The communication of the critical audit matter does not alter in any way our opinion on the financial statements, taken as a whole, and we are not, by communicating the critical audit matter below, providing separate an opinion on the critical audit matter or on the accounts or disclosures to which it relates. As described in Note 2 to the financial statements, the Company records expenses of research and development activities, including nonclinical studies, and third-party contract services for clinical trials and manufacturing development. Clinical trials and contract manufacturing activities performed by third parties are expensed based upon estimates of work completed with respective contract research organizations (“CROs”) or contract manufacturing organizations (“CMOs”) and other third-party vendors. Though expenses are based on signed agreements, the complexity involved in determining expenses arises from agreements containing multiple milestones that require management’s careful analysis with external parties to determine period expenses and potential contractual milestone expenses based on the progress made against benchmarks including but not limited to patients enrolled, services performed, and equipment purchased. During 2024, the Company incurred $78.0 million of research and development expenses. The Company recorded an accrued liability of $3.9 million for expenses incurred but not yet invoiced, and a prepaid expense of $4.2 million for payments made to vendors in excess of costs incurred. Given the significant judgments and estimates in accounting for research and development expenses, we have determined this area to be a critical audit matter. F- 2 Our audit procedures related to research and development costs included the following procedures, among others: • For a sample of significant clinical trials and contract manufacturing services, we o Inspected the related contracts, purchase orders, statements of work and other contractual documentation. o Tested the completeness and accuracy of the underlying data used to develop the estimates. o Performed corroborating inquiries with the Company’s research and development and finance personnel. o Inspected information from third-party service providers to understand the nature and progress of the studies and confirmed study related data directly with certain third-party service providers. o Inspected third-party service provider invoices and evidenced corresponding payments. /s/ RSM US LLP We have served as the Company’s auditor since 2019. Boston, Massachusetts March 27, 2025 F- 3 Savara Inc. and Subsidiaries Consolidated Ba lance Sheets (in thousands, except for share and per share amounts) As of December 31, 2024 2023 Assets Current assets: Cash and cash equivalents $ 15,128 $ 26,585 Short-term investments 181,199 135,734 Prepaid expenses and other current assets 5,808 3,628 Total current assets 202,135 165,947 Property and equipment, net 165 270 In-process R&D 10,337 10,960 Other non-current assets 242 387 Total assets $ 212,879 $ 177,564 Liabilities and stockholders’ equity Current liabilities: Accounts payable $ 4,545 $ 3,504 Accrued expenses and other current liabilities 10,179 7,093 Total current liabilities 14,724 10,597 Long-term liabilities: Long-term debt 26,619 26,348 Other long-term liabilities 87 247 Total liabilities 41,430 37,192 Commitments and contingencies (Note 10) Stockholders’ equity: Common stock, $ 0.001 par value, 300,000,000 shares authorized as of December 31, 2024 and 2023; 172,423,223 and 138,143,545 shares issued and outstanding as of December 31, 2024 and 2023, respectively 173 140 Additional paid-in capital 661,276 533,872 Accumulated other comprehensive loss ( 750 ) ( 271 ) Accumulated deficit ( 489,250 ) ( 393,369 ) Total stockholders' equity 171,449 140,372 Total liabilities and stockholders' equity $ 212,879 $ 177,564 The accompanying notes are an integral part of these consolidated financial statements. F- 4 Savara Inc. and Subsidiaries Consolidated Statem ents of Operations and Comprehensive Loss (in thousands, except for share and per share amounts) Years ended December 31, 2024 2023 Operating expenses: Research and development $ 78,029 $ 44,262 General and administrative 25,037 15,668 Depreciation and amortization 130 77 Total operating expenses 103,196 60,007 Loss from operations ( 103,196 ) ( 60,007 ) Other income, net: Interest income, net 6,467 4,436 Foreign currency exchange gain 51 76 Tax credit income 797 797 Total other income, net 7,315 5,309 Net loss $ ( 95,881 ) $ ( 54,698 ) Net loss per share: Basic and diluted $ ( 0.48 ) $ ( 0.33 ) Weighted-average common shares outstanding: Basic and diluted 198,191,936 165,204,652 Other comprehensive income (loss): Gain (loss) on foreign currency translation ( 523 ) 133 Unrealized gain on short-term investments 44 201 Total comprehensive loss $ ( 96,360 ) $ ( 54,364 ) The accompanying notes are an integral part of these consolidated financial statements. F- 5 Savara Inc. and Subsidiaries Consolidated Statements o f Changes in Stockholders’ Equity Years Ended December 31, 2024 and 2023 (in thousands, except share amounts) Stockholders’ Equity Common Stock Accumulated Number of Shares Amount Additional Paid-In Capital Accumulated Deficit Other Comprehensive Income (Loss) Total Balance on December 31, 2022 114,046,345 $ 116 $ 446,938 $ ( 338,671 ) $ ( 605 ) $ 107,778 Issuance of common stock and pre-funded warrants in underwritten public offering, net of offering cost 21,000,000 21 74,853 — — 74,874 Issuance of common stock upon exercise of stock options 245,786 — 283 — — 283 Issuance of common stock for settlement of RSUs 1,062,000 1 ( 1 ) — — — Repurchase of shares for minimum tax withholdings ( 282,097 ) — ( 1,208 ) — — ( 1,208 ) Issuance of common stock upon at the market offerings, net 2,071,511 2 8,829 8,831 Stock-based compensation — — 4,178 — — 4,178 Foreign exchange translation adjustment — — — — 133 133 Unrealized gain on short-term investments — — — — 201 201 Net loss — — — ( 54,698 ) — ( 54,698 ) Balance on December 31, 2023 138,143,545 $ 140 $ 533,872 $ ( 393,369 ) $ ( 271 ) $ 140,372 Issuance of common stock in underwritten public offering, net of offering cost 26,246,720 26 93,772 — — 93,798 Issuance of common stock upon at the market offerings, net 6,038,650 6 24,368 — — 24,374 Issuance of common stock upon exercise of stock options 388,185 — 347 — — 347 Issuance of common stock for settlement of RSUs 1,117,750 1 ( 1 ) — — — Repurchase of shares for minimum tax withholdings ( 286,627 ) — ( 995 ) — — ( 995 ) Issuance of common stock upon exercise of prefunded warrants 775,000 — 7 — — 7 Reimbursement of commissions from prior issuance of common stock upon at the market sales, net — — 46 — — 46 Stock-based compensation — — 9,860 — — 9,860 Foreign exchange translation adjustment — — — — ( 523 ) ( 523 ) Unrealized gain on short-term investments — — — — 44 44 Net loss — — — ( 95,881 ) — ( 95,881 ) Balance on December 31, 2024 172,423,223 $ 173 $ 661,276 $ ( 489,250 ) $ ( 750 ) $ 171,449 The accompanying notes are an integral part of these consolidated financial statements. F- 6 Savara Inc. and Subsidiaries Consolidated Statem ents of Cash Flows (in thousands) Years ended December 31, 2024 2023 Cash flows from operating activities: Net loss $ ( 95,881 ) $ ( 54,698 ) Adjustments to reconcile net loss to net cash used in operating activities: Depreciation and amortization 130 77 Reduction in the carrying value of right-of-use assets 145 98 Foreign currency loss — ( 76 ) Amortization of debt issuance costs 271 271 Accretion on discount to short-term investments ( 5,442 ) ( 4,984 ) Stock-based compensation 9,860 4,178 Changes in operating assets and liabilities: Prepaid expenses and other current assets ( 2,383 ) ( 456 ) Non-current assets 11 ( 12 ) Accounts payable and accrued expenses and other current liabilities 4,201 4,541 Net cash used in operating activities ( 89,088 ) ( 51,061 ) Cash flows from investing activities: Purchase of property and equipment ( 25 ) ( 296 ) Purchase of available-for-sale securities, net ( 204,916 ) ( 194,220 ) Maturity of available-for-sale securities 165,000 137,400 Net cash used in investing activities ( 39,941 ) ( 57,116 ) Cash flows from financing activities: Issuance of common stock and pre-funded warrants in underwritten offering, net of offering costs — 74,874 Issuance of common stock issued in underwritten offering, net of offering costs 93,798 — Issuance of common stock upon exercise of prefunded warrants 7 — Issuance of common stock upon at the market offerings, net 24,374 8,831 Proceeds from exercise of stock options 347 283 Reimbursement of commissions from the prior issuance of common stock upon at the market sales, net 46 — Repurchase of shares for minimum tax withholdings ( 995 ) ( 1,208 ) Net cash provided by financing activities 117,577 82,780 Effect of exchange rate changes on cash and cash equivalents ( 5 ) ( 118 ) Decrease in cash and cash equivalents ( 11,457 ) ( 25,515 ) Cash and cash equivalents beginning of period 26,585 52,100 Cash and cash equivalents end of period $ 15,128 $ 26,585 Supplemental disclosure of cash flow information: Cash paid for interest $ 2,124 $ 2,040 The accompanying notes are an integral part of these consolidated financial statements. F- 7 Savara Inc. and Subsidiaries Notes to Consolidated Financial Statements 1. Description of Business and Basis of Presentation Description of Business Savara Inc. (together with its subsidiaries “Savara,” the “Company,” “we” or “us”) is a clinical-stage biopharmaceutical company focused on rare respiratory diseases. The Company’s 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 proteinosis (“aPAP”). The Company and its wholly-owned domestic and foreign subsidiaries operate in one segment with its principal office in Langhorne, Pennsylvania, though a significant portion of employees work remotely. Since inception, Savara has devoted its efforts and resources to identifying and developing its product candidates, recruiting personnel, and raising capital. Savara has incurred operating losses and negative cash flow from operations and has no product revenue from inception to date. The Company has not yet commenced commercial operations. 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”). 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 loss . All intercompany transactions and accounts have been eliminated in consolidation. Liquidity As of December 31, 2024, the Company had an accumulated deficit of approximately $ 489.3 million . The Company used cash from operations of approximately $ 89.1 million for the year ended December 31, 2024. 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 MOLBREEVI 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 Company’s 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 $ 15.1 million and short-term investments of $ 181.2 million as of December 31, 2024, which is sufficient to fund the Company's operations for at least the next twelve months subsequent to the issuance date of its consolidated financial statements for the year ended December 31, 2024. 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. The Company currently maintains depository accounts and has a debt facility with Silicon Valley Bank, an FDIC insured entity. 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. and FNZ, refer to Note 5. Short-term Investments and Note 8. Fair Value Measurements . F- 8 Use of Estimates The preparation of consolidated financial statements in conformity with U.S. GAAP requires the Company to make certain estimates and assumptions that affect the amounts reported in the consolidated financial statements and accompanying notes. Management’s estimates include those related to the accrual of research and development and general and administrative costs, certain financial instruments recorded at fair value, stock-based compensation, and the valuation allowance for deferred tax assets. The Company bases its estimates on historical experience and on various other market-specific and relevant assumptions that it believes to be reasonable under the circumstances. Accordingly, actual results could be materially different from those estimates. Risks and Uncertainties The product candidate being developed by the Company requires approval from the U.S. Food and Drug Administration (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 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. We review investments for impairment whenever the fair value of an available-for-sale security is less than the amortized cost and evidence indicates that an investment’s carrying amount is not recoverable. Unrealized losses are evaluated for impairment under ASC 326, Financial Instruments - Credit Losses, to determine if the impairment is credit-related or noncredit-related. Credit-related impairment is recognized as an allowance on the balance sheet with a corresponding adjustment to net loss, and noncredit-related impairment is recognized in other comprehensive (loss) income, net of taxes. 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. 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 and cash equivalents and marketable securities to the extent recorded on the consolidated balance sheets. 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 F- 9 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. 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. Acquired In-Process Research and Development In accordance with ASC Topic 350, Intangibles – Goodwill and Other , the Company's acquired IPR&D is determined to have an indefinite life 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. 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. 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 30th, utilizing a qualitative approach and determining if it was more-likely-than not that the fair value was impaired. Our determinations as to whether, and if so, the extent to which 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. F- 10 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. 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. The Company’s financial instruments consist primarily of cash, cash equivalents, short term investments, accounts payable, and accrued liabilities. The Company’s cash, cash equivalents, accounts payable, and accrued liabilities F- 11 approximate fair value due to their relatively short maturities. 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 expects to commence in the upcoming year(s), 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 13. 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 11. 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 12. Income Taxes for additional discussion. Recent Accounting Pronouncements In November 2023, the FASB issued Accounting Standards Update ("ASU") 2023-07, Segment Reporting (Topic 280): Improvements to Reportable Segment Disclosures (" ASU 2023-07"), to provide more disaggregated expense information about a public entity’s reportable segments. The amendments in this update should be applied retrospectively and are effective for fiscal years beginning after December 15, 2023, and interim periods beginning after December 15, 2024. As of January 1, 2024 , we have adopted ASU 2023-07 which did no t have a material impact on the Company's consolidated financial statements and additional required disclosures have been included in Note 13. Segment Reporting. In December 2023, the FASB issued ASU 2023-09, Income Taxes (Topic 740): Improvements to Income Tax Disclosures ("ASU 2023-09"), to require disaggregated information about a reporting entity’s effective tax rate reconciliation as well as information on income taxes paid. The amendments in this update should be applied prospectively, with an option to apply them retrospectively, and are effective for fiscal years beginning after December 15, 2024 for public entities. We began an assessment of the impact that this guidance will have on our consolidated financial statements and related disclosures, and our analysis is currently ongoing. In March 2024, the FASB issued ASU 2024-03, Income Statement – Reporting Comprehensive Income – Expense Disaggregation Disclosures (Subtopic 220-40): Disaggregation of Income Statement Expenses (" ASU 2024-03"), to improve the disclosures about a public business entity’s expenses and to provide more detailed information about the types of expenses in commonly presented expense captions. The amendments in this update should be applied either prospectively or retrospectively, and are effective for fiscal years beginning after December 15, 2026, and interim periods beginning after December 15, 2027. We began an assessment of the impact that this guidance will have on our consolidated financial statements and related disclosures, and our analysis is currently ongoing. F- 12 3. Prepaid Expenses and Other Current Asset s Prepaid expenses, consisted of (in thousands): December 31, 2024 2023 Prepaid contracted research and development costs $ 4,179 $ 2,167 R&D tax credit receivable 768 814 VAT receivable 275 191 Prepaid insurance 131 176 Deposits and other 455 280 Total prepaid expenses and other current assets $ 5,808 $ 3,628 Prepaid Contracted Research and Development Costs As of December 31, 2024, Prepaid contracted research and development costs are primarily comprised of contractual prepayments associated with the Company's clinical trial for MOLBREEVI for the treatment of aPAP and for CMC related activities. 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. R&D Tax Credit Receivable The Company has recorded a Danish R&D tax credit receivable earned by its subsidiary, Savara ApS, as of December 31, 2024 . 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, 2023, the Company generated a Danish R&D tax credit receivable of $ 0.8 million which was received in the fourth quarter of 2024. During the year ended December 31, 2024 , the Company generated a Danish R&D tax credit receivable of $ 0.8 million which is expected to be received in the fourth quarter of 2025. 4. Accrued Expenses and Other Current Liabilities Accrued expenses and other liabilities, consisted of (in thousands): December 31, 2024 2023 Accrued compensation $ 5,017 $ 4,046 Accrued contracted research and development costs 3,912 2,166 Accrued general and administrative costs 1,134 738 Lease liability 116 143 Total accrued expenses and other current liabilities $ 10,179 $ 7,093 Accrued Compensation As of December 31, 2024, 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, 2024, Accrued contracted research and development costs are primarily comprised of costs associated with MOLBREEVI 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. F- 13 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, 2024 Amortized Cost Gross Unrealized Gains Gross Unrealized Losses Fair Value Short-term investments U.S. government securities $ 180,961 $ 255 $ ( 17 ) $ 181,199 Total short-term investments $ 180,961 $ 255 $ ( 17 ) $ 181,199 As of December 31, 2023 Amortized Cost Gross Unrealized Gains Gross Unrealized Losses Fair Value Short-term investments U.S. government securities $ 135,541 $ 194 $ ( 1 ) $ 135,734 Total short-term investments $ 135,541 $ 194 $ ( 1 ) $ 135,734 The Company has classified its investments as available-for-sale securities. These securities are carried at estimated fair value with the aggregate unrealized gains and losses related to these investments reflected as a part of Accumulated other comprehensive loss 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, as further discussed in Note 8. Fair Value Measurements. There were no significant realized gains or losses related to investments for the years ended December 31, 2024 and 2023 . 6. Property and Equipment, Net Property and equipment, net consisted of (in thousands): December 31, 2024 2023 Research and development equipment $ 1,102 $ 1,102 Equipment 772 737 Furniture and fixtures 120 110 Leasehold improvements 333 333 Total property and equipment 2,327 2,282 Less accumulated depreciation ( 2,162 ) ( 2,012 ) Property and equipment, net $ 165 $ 270 Depreciation expense for the years ended December 31, 2024 and 2023 was minimal. 7. Debt Facility On April 21, 2022 , the Company and its subsidiary, Aravas Inc. (“Aravas”) entered into an Amended and Restated Loan and Security Agreement (the “Amended Loan Agreement”), as co-borrowers with Silicon Valley Bank, a division of First Citizens BancShares, as lender (the “Lender”) which provides for a $ 26.5 million term loan facility. 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 %. The Company 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 currently prepay the loan in whole or in part at any time without penalty or prepayment fee. The Lender 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 contains 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 F- 14 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). The Company was obligated to issue warrants to purchase shares of its common stock as part of the initial funding of the loan, as further described in Note 9. Stockholders’ Equity . 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 income (expense) line item in our consolidated statement of operations. Summary of Carrying Value The following table summarizes the components of the long-term debt carrying value, which approximates the fair value (in thousands): Future minimum payments due during the year ended December 31, 2025 $ - 2026 17,667 2027 9,562 Total future minimum payments 27,229 Unamortized end of term charge ( 333 ) Debt issuance costs ( 253 ) Debt discount related to warrants ( 24 ) Total debt 26,619 Current portion of long-term debt — Long-term debt $ 26,619 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, 2024 and 2023 was as follows (in thousands): Quoted Prices in Active Markets for Identical Assets (Level 1) Significant Other Observable Inputs (Level 2) Significant Unobservable Inputs (Level 3) Total As of December 31, 2024 Cash equivalents: U.S. Treasury money market funds $ 13,802 $ — $ — $ 13,802 Short-term investments: U.S. government securities 181,199 — — 181,199 As of December 31, 2023 Cash equivalents: F- 15 U.S. Treasury money market funds $ 17,270 $ — $ — $ 17,270 Short-term investments: U.S. government securities 135,734 — — 135,734 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, 2024 and 2023. 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, 2024 and 2023, the Company had IPR&D of approximately $ 10.3 million and $ 11.0 million, respectively. For the years ended December 31, 2024 and 2023, the Company experienced a decrease of approximately $ 0.6 million and an increase of approximately $ 0.3 million, respectively, in the carrying value of IPR&D, which was due to foreign currency translation. 9. Stockh olders’ Equity Underwritten Offering of Common Stock July 2024 On July 1, 2024, the Company sold an aggregate of 26,246,720 shares of the Company’s common stock, par value $ 0.001 per share, pursuant to an underwritten offering of its common stock (the "July 2024 Offering") at an offering price of $ 3.81 per share. The July 2024 Offering was made pursuant to the Registration Statement on Form S-3 (File No. 333-279274), which was filed with the SEC on May 9, 2024 and declared effective on May 21, 2024 (the "2024 Registration Statement"), and a prospectus supplement filed with the SEC on June 28, 2024. The July 2024 Offering resulted in net proceeds of $ 93.8 million after taking into consideration underwriter commissions, legal fees, and other customary closing costs, as follows (in thousands): Financial instruments Proceeds Common stock $ 100,000 Offering expenses ( 6,201 ) Net proceeds $ 93,799 July 2023 On July 17, 2023, the Company sold (i) an aggregate of 21,000,000 shares of the Company’s common stock for $ 3.00 per share which represented a 1 % premium over the closing price on that date and (ii) pre-funded warrants to purchase an aggregate of 5,666,667 shares of the Company's common stock at an exercise price of $ 0.001 per share (the “2023 Pre-Funded Warrants”) for $ 2.999 per warrant pursuant to an underwritten offering (the “July 2023 Offering”). The Company determined that the securities issued in the July 2023 Offering were free-standing and that the 2023 Pre-Funded Warrants meet the equity classification requirements pursuant to ASC 480, Distinguishing Liability from Equity , ASC 815, Derivatives and Hedging and Subtopic 815-40, Accounting for Convertible Instruments and Contracts in an Entity’s Own Equity . The 2023 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 July 2023 Offering resulted in net proceeds to the Company of approximately $ 74.9 million, after deducting final underwriting discounts, commissions, and other estimated offering expenses, as follows (in thousands): Financial instruments Proceeds Common stock $ 63,000 2023 Pre-funded warrants 16,994 Total 79,994 Offering expenses $ ( 5,120 ) Net proceeds $ 74,874 F- 16 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 $ 100.0 million. The Sales Agreement was effective on July 16, 2021 , the date the Company’s Registration Statement on Form S-3 (File No. 333-257709) (the “2021 Registration Statement”), filed with the SEC on July 6, 2021, was declared effective by the SEC. From July 16, 2021 through May 20, 2024, Shares were sold pursuant to the 2021 Registration Statement. Since May 21, 2024, the Shares have been offered and sold pursuant to the 2024 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, 2024 and 2023 , the Company sold 6,038,650 shares of the Company’s common stock resulting in net proceeds of $ 24.4 million and 2,071,511 shares of common stock resulting in net proceeds of $ 8.8 million to a single institutional investor pursuant to the Sales Agreement, respectively. Common Stock The Company’s amended and restated certificate of incorporation, as amended, authorizes the Company to issue 301,000,000 shares of capital stock, consisting of 300,000,000 shares of common stock with $ 0.001 par value per share and 1,000,000 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, 2024 and 2023: December 31 2024 2023 Common stock authorized 300,000,000 300,000,000 Common stock outstanding 172,423,223 138,143,545 The Company’s shares of common stock reserved for issuance as of December 31, 2024 and 2023 were as follows: December 31, 2024 2023 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 Pre-funded PIPE Warrants 5,780,537 5,780,537 2021 Pre-funded Warrants 32,175,172 32,175,172 2023 Pre-funded Warrants 5,666,667 5,666,667 Stock options outstanding 13,554,621 9,633,067 Issued and non-vested RSUs 4,677,500 3,488,250 Total shares reserved 61,932,290 57,596,486 Warrants The following table summarizes the outstanding warrants for the Company’s common stock as of December 31, 2024: Expiration Date Shares Underlying Outstanding Warrants Exercise Price April 2027 24,725 $ 2.87 June 2027 41,736 $ 2.87 December 2028 11,332 $ 2.87 None 43,622,376 $ 0.001 43,700,169 F- 17 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, 2022 $ ( 594 ) $ ( 11 ) $ ( 605 ) Change 133 201 334 Balance, December 31, 2023 $ ( 461 ) 190 $ ( 271 ) Change ( 523 ) 44 ( 479 ) Balance, December 31, 2024 $ ( 984 ) $ 234 $ ( 750 ) 10. Comm itments Operating Leases The Company is obligated under an operating lease, as amended, for commercial real estate located in Langhorne, Pennsylvania, the Company’s headquarters. On February 28, 2023, the Company entered into the first amendment (the “Lease Amendment”) to its existing lease agreement, dated July 7, 2021 and which originally commenced on October 1, 2021 . The Lease Amendment commenced on July 1, 2023 , continues through June 30, 2026 , or an additional thirty-six months , expands the existing office space, and increases the average monthly rent to approximately $ 14.5 thousand, paid over monthly installments during the Lease Amendment term. As of December 31, 2024, the carrying value of the right-of-use assets for the operating lease was $ 0.2 million, which is reflected in Other non-current assets and the carrying value of the lease liabilities for the operating lease increased to $ 0.3 million, of which approximately $ 0.2 million related to the current portion of the lease liabilities is recorded in Accrued expenses and other current liabilities and approximately $ 0.1 million related to the non-current portion of the lease liabilities is recorded in Other long-term liabilities . The following is a maturity analysis of the annual undiscounted cash flows reconciled to the carrying value of the operating lease liabilities as of December 31, 2024 (in thousands): Year ending December 31, 2025 $ 160 2026 87 Total future minimum lease payments $ 247 Less imputed interest ( 17 ) Total $ 230 Operating cash flows from operating leases $ 172 Weighted-average remaining lease term (in months) - operating leases 18 Weighted-average discount rate - operating leases 7.8 % F- 18 Manufacturing and Other Commitments and Contingencies The Company is subject to various royalties and manufacturing and development payments related to its product candidate, MOLBREEVI . Under a manufacture and supply agreement with an active pharmaceutical ingredients (“API”) manufacturer for MOLBREEVI , as amended, the Company must make certain payments to the API manufacturer upon achievement of the milestones outlined in the table set forth below. Additionally, upon first receipt of marketing approval by the Company from a regulatory authority in a country for a product containing the API for therapeutic use in humans and ending the earlier of (i) ten (10) years thereafter or (ii) the date a biosimilar of such product is first sold in such country, the Company shall pay the API manufacturer a royalty equal to low-single digits of the net sales in that country of products containing API supplied by the API manufacturer. Additionally, the Company is subject to a purchase requirement under which for ten years following the date of receipt of approval by a regulatory authority of the first regulatory filing for the marketing and sale of the first product containing the API in any country, the Company will purchase from the API manufacturer the API required to produce a percentage of such product it sells each year (the “Purchase Requirement”); provided, however, that the Purchase Requirement will no longer apply if (i) the price charged by the API manufacturer exceeds a certain price charged by an alternative supplier, (ii) there is a shortage of supply, or (iii) API manufacturer at any time fails to materially fulfill a purchase order of the Company. 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 MOLBREEVI . In addition to these milestones, the Company will owe a royalty of three-and one-half percent ( 3.5 %) to the manufacturer of the nebulizer based on net sales. The following table summarizes manufacturing commitments and contingencies as of the period indicated (in thousands): Manufacturing, Development, and Other Contingent Milestone Payments (in thousands): December 31, 2024 MOLBREEVI manufacturer: Achievement of certain milestones related to validation of API and regulatory approval of MOLBREEVI $ 320 MOLBREEVI nebulizer manufacturer: Achievement of various development activities and regulatory approval of nebulizer utilized to administer MOLBREEVI 521 Total manufacturing and other commitments $ 841 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, 2024. Further, in February 2024, the Company entered into a master services agreement with an additional manufacturer to provide development and manufacturing services related to API for the Company’s MOLBREEVI product candidate in accordance with the terms of separate scope of work agreements and to perform a manufacturing campaign for process performance qualification of the API of MOLBREEVI. Under that master services agreement, work orders and subsequent change orders, the Company is currently obligated to pay the second source manufacturer, in total, estimated fees of $ 24.7 million of which $ 15.9 million has been recognized as expense during the year ended December 31, 2024. No expense was recognized in relation to this master services agreement during the year ended December 31, 2023. These costs are subject to various cancellation fees ranging from ten percent ( 10 %) to one hundred percent ( 100 %) of the cost of the respective activity based upon the timing of the commencement date and status of the activity. Contract Research As part of its development of MOLBREEVI for the treatment of aPAP, the Company entered into a Master Services Agreement (“MSA”) with Parexel International (IRL) Limited (“Parexel”) pursuant to which Parexel will provide contract research services related to clinical trials. Contemporaneously with entering the MSA, a work order was executed with Parexel, under which they will provide services related to the IMPALA-2 trial. Under that work order and subsequent change orders, the Company is obligated to pay Parexel service fees, pass-through expenses, and investigator fees estimated to be approximately $ 48.5 million over the course of the IMPALA-2 clinical trial and trial close-out activities of which $ 9.2 million and $ 10.8 million has been recognized as expense during the years ended December 31, 2024 and 2023, respectively. In the second quarter of 2024, the Company initiated an open-label, multicenter clinical trial of MOLBREEVI in pediatric subjects with aPAP ("IMPACT") under a separate work order with Parexel. Pursuant to the IMPACT trial, Parexel currently F- 19 has the opportunity to earn up to approximately $ 4.8 million in various milestone payments primarily dependent upon patient enrollment, site management, project oversight and the compliance with defined study protocols of which $ 1.3 million was recognized in the year ended December 31, 2024. No expense was recognized in relation to this work order during the year ended December 31, 2023. 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 Chief Executive Officer ("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 based upon the number of days he was employed by the Company during the relevant performance period, (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 upon 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, (ii) 100% of the unpaid target bonus, (iii) a pro-rated portion of the unpaid target bonus based on the number of days he was employed by the Company during the relevant performance period, (iv) reimbursement for continued coverage under medical benefit plans for 24 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 24-month anniversary of the termination date or (y) the original expiration date. Each of the Company’s Chief Financial & Administrative Officer (“CFO”), Chief Medical Officer (“CMO”), Chief Operating Officer ("COO"), Chief Business Officer ("CBO"), and Chief Commercial Officer ("CCO") is entitled to payments and benefits if the CFO, CMO, COO, CBO, or CCO, respectively, is (i) terminated without cause, (ii) terminated due to 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, (i i) 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 upon resignation for good reason within three months prior to or 12 months following a change in control, the CFO, CMO, COO, CBO, or CCO 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. 11. Stock -Based Compensation A. Equity Incentive Plans The Company’s 2024 Omnibus Incentive Plan (the “2024 Plan”) was adopted by the Company’s board of directors in March 2024, was approved by the Company’s stockholders on June 6, 2024, and became effective on June 7, 2024. The 2024 Plan was intended to replace the Company’s Amended and Restated 2015 Omnibus Incentive Plan (the “2015 Plan”), and upon the effectiveness of the 2024 Plan, no further grants may be made under the 2015 Plan. All outstanding awards under the 2015 Plan will continue in accordance with the 2015 Plan and any award agreement executed in connection with such outstanding awards. The 2024 Plan provides for the grant of stock options (both incentive stock options and non-statutory stock options), stock appreciation rights, restricted stock, restricted stock units (“RSUs”), performance units, shares, and other stock-based awards. Stock-based awards are subject to terms and conditions established by the board of directors or the compensation committee of the board of directors. As of December 31, 2024 , the number of shares of common stock available for grant under the 2024 Plan was 7,153,602 shares. F- 20 The Company’s 2021 Inducement Equity Incentive Plan (the “Inducement Plan”) was adopted by the Company’s board of directors in May 2021 and subsequently amended to increase the shares available for grant. The Inducement Plan provides for the grant of non-statutory stock options, restricted stock, RSUs, stock appreciation rights, performance units, and 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, 2024 , the number of shares of common stock available for grant under the Inducement Plan was 1,272,799 shares. Under the Inducement Plan and 2024 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 . The Savara Inc. Stock Option Plan (the “2008 Plan”) was adopted in 2008, and the Company no longer issues awards under the 2008 Plan. As of December 31, 2024 , the Company had options outstanding to purchase 139,332 shares of common stock under the 2008 Plan. The outstanding awards granted under the 2008 Plan are fully vested and generally have a maximum contractual term of ten 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 the Equity Incentive Plans The following table summarizes the assumptions used for estimating the fair value of stock options granted to employees for the years ended December 31, 2024 and 2023: 2024 2023 Risk-free interest rate 3.58 % - 4.55 % 3.37 % - 4.80 % Expected term (years) 6.06 - 9.26 6.06 Expected volatility 90.9 % - 114.6 % 91.2 % - 97.84 % 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, 2024: 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, 2023 9,633,067 $ 2.42 7.94 $ 25,392 Granted 4,573,000 3.47 6.08 Exercised ( 464,297 ) 1.49 $ 1,327 Expired/cancelled/forfeited ( 187,149 ) 1.78 Outstanding at December 31, 2024 13,554,621 $ 2.79 7.89 $ 11,586 Options exercisable at December 31, 2024 6,220,508 $ 2.47 6.29 $ 8,728 The weighted-average grant date fair values for the Company’s stock options granted during the years ended December 31, 2024 and 2023 were $ 3.47 per share and $ 2.79 per share, respectively. The total compensation cost related to non-vested stock options not yet recognized as of December 31, 2024 was $ 18.4 million, which will be recognized over a weighted-average period of approximately 3.5 years. F- 21 During the years ended December 31, 2024 and 2023 , 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, 2024 and 2023 , respectively. RSUs: Shares Underlying Option Awards Weighted-Average Grant Date Fair Value Outstanding at December 31, 2023 3,488,250 $ 3.36 Granted 2,409,500 3.58 Vested ( 1,117,750 ) 1.81 Expired/cancelled/forfeited ( 102,500 ) — Outstanding at December 31, 2024 4,677,500 $ 3.83 The total compensation cost related to unvested RSUs not yet recognized as of December 31, 2024 was $ 11.7 million, which will be recognized over a weighted-average period of 1.4 years. E. Stock-Based Compensation Stock-based compensation expense is included in the following line items in the accompanying consolidated statements of operations and comprehensive loss for the years ended December 31, 2024 and 2023 (in thousands): Year ended December 31, 2024 2023 Research and development $ 4,453 $ 1,470 General and administrative 5,407 2,708 Total stock-based compensation $ 9,860 $ 4,178 12. Inc ome Taxes The components of loss before income taxes for the years ended December 31, 2024 and 2023 are as follows (in thousands): December 31, 2024 2023 Domestic $ ( 63,256 ) $ ( 40,834 ) Foreign ( 32,625 ) ( 13,864 ) Total $ ( 95,881 ) $ ( 54,698 ) The Company did no t record a federal tax benefit or expense for the years ended December 31, 2024 and 2023. The Company recorded a minimal state provision for income taxes for the year ended December 31, 2024 and no state provision for income taxes for the year ended December 31, 2023 due to revenues below the minimum tax threshold. The components of the income tax expense are as follows for the years ended December 31, 2024 and 2023 (in thousands): December 31, 2024 2023 Current: Federal $ — $ — State 9 — Foreign — — Total Current 9 — Deferred: Federal — — State — — Foreign — — Total Deferred — — Total income tax expense $ 9 $ — F- 22 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, 2024 and 2023 (in thousands): December 31, 2024 2023 Income tax benefit computed at federal statutory tax rate $ ( 20,135 ) $ ( 11,487 ) State taxes, net of federal 7 — Change in valuation allowance 29,911 18,957 Orphan drug & research credits generated ( 9,659 ) ( 6,998 ) Impact of foreign operations ( 338 ) ( 136 ) Foreign deferred tax asset - true up ( 750 ) ( 1,124 ) Actualization and deferred tax asset - true up ( 214 ) — Imputed interest 1,498 1,309 Permanent differences ( 311 ) ( 537 ) Other — 16 Total $ 9 $ — 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, 2024 and 2023, the valuation allowance increased by $ 33.5 million and $ 23.0 million, respectively. Significant components of the Company’s deferred tax assets and liabilities are as follows (in thousands): December 31, 2024 2023 Deferred tax liabilities: ROU assets $ 67 $ 108 Other 687 783 Total deferred tax liabilities 754 891 Deferred tax assets: Net operating loss carryforwards 58,384 44,731 Intangible assets 379 1,398 Amortization 1,263 1,400 Credit carryforwards 22,624 12,965 Section 174 research and development expenses 20,058 11,638 ROU liabilities 56 108 Depreciation 272 245 Accrued liabilities & other 5,074 2,304 Total deferred tax assets 108,110 74,789 Subtotal 107,356 73,898 Valuation allowance ( 107,356 ) ( 73,898 ) Net deferred taxes $ — $ — 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 and private issuance of common stock on several occasions which have ultimately resulted in multiple changes in ownership, as defined by Section 382. As of December 31, 2024 and 2023, the Company still has $ 52.4 million of federal Section 382 NOLs, collectively, which are included in the federal NOL carryforwards below, that are severely limited in future years. As of December 31, 2024 and 2023, the Company had foreign NOL carryforwards of approximately $ 137.7 million and $ 96.0 million, respectively, which have an indefinite carryforward period. After taking the Section 382 limitations discussed into account, as of December 31, 2024 and 2023 , the Company had NOLs for federal income tax purposes of approximately $ 126.0 million and $ 109.4 million, respectively. Federal NOL carryforwards of $ 5.2 million begin to expire in 2037 , with $ 120.8 million not having an expiration date. As of December 31, 2024 and 2023 , the Company had state NOL F- 23 carryforwards of approximately $ 25.0 million and $ 9.5 million, respectively. The state NOL carryforwards begin to expire in 2038 . As of December 31, 2024 and 2023 , the Company also had available research and orphan drug tax credit carryforwards for federal income tax purposes of approximately $ 22.1 million and $ 12.5 million, respectively. If not utilized, these carryforwards expire at various dates beginning in 2039 . As of December 31, 2024 and 2023 , the Company had state research and development tax credit carryforwards of approximately $ 0.5 million and $ 0.5 million, respectively, which will begin to expire i n 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, 2024 and 2023 , the Company had no unrecognized tax benefits. During the years ended December 31, 2024 and 2023 , 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, 2024, the statute of limitations for assessment by the Internal Revenue Service (“IRS”) is ope n for the 2020 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 2019 and subsequent tax years remain open and subject to examination by the state taxing authorities. The 2020 a nd 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. 13. Segment Reporting We follow the accounting guidance of ASC Topic 280, Segment Reporting , which establishes standards for companies to report in their financial statement information about operating segments, products, services, geographic areas, and major customers. Operating segments are defined as components of an enterprise engaging in business activities for which separate financial information is available that is regularly evaluated by the Company’s chief operating decision-makers in deciding how to allocate resources and assess performance. The Company’s chief operating decision maker (“CODM”) has been identified as the Chief Executive Officer , who reviews consolidated results including operating expenses and operating losses at a consolidated level only. The Company and its CODM do not distinguish between potential markets for the purpose of making decisions about resource allocation and performance assessment of its sole pre-revenue development program, MOLBREEVI, for the treatment of aPAP. Therefore, the Company has only one operating segment and one reportable segment, specialty pharmaceuticals within the respiratory system. The Company's only significant long-lived asset, IPR&D, is located in Denmark, and the Company currently does not generate any revenues and its operating expenses and losses are viewed on a consolidated basis by the CODM. Therefore, no geographical segmen ts are presented. In addition to the significant expense categories included on the Company's consolidated statements of operations, refer below for disaggregated amounts that comprise research and development expenses and the segment net loss (in thousands): Year Ended December 31, 2024 2023 Operating expenses: Research and development operating costs and expenses excluding non-cash stock-based compensation: Primary program research and development expenses (a) $ 59,325 $ 32,535 Other research and development expenses: Payroll and benefits 11,933 9,023 Occupancy and other overhead and operating costs 2,318 1,234 Total other research and development expenses 14,251 10,257 Research and development operating costs and expenses excluding non-cash stock-based compensation: 73,576 42,792 General and administrative expense excluding non-cash stock-based compensation 19,630 12,960 Other segment income (expense), net (b) 2,675 ( 1,054 ) Segment net loss $ ( 95,881 ) $ ( 54,698 ) (a) Primary program research and development expenses are comprised primarily of costs paid to third parties for clinical trials and product development manufacturing, nonclinical, regulatory, and quality assurance activities, and the portion of related research and development expenses incurred by our collaborators and third-party service providers, including contract research and manufacturing organizations that we are obligated to reimburse. F- 24 (b) Other segment income (expense), net includes interest income, interest expense, foreign currency exchange gain or loss, depreciation and amortization, non-cash stock-based compensation and tax credit income. 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, 2024 and 2023, potentially dilutive securities include: Year ended December 31, 2024 2023 Awards under equity incentive plan 13,554,621 9,633,067 Non-vested restricted shares and restricted stock units 4,677,500 3,488,250 Warrants to purchase common stock 77,793 77,793 Total 18,309,914 13,199,110 The following table calculates basic net loss per share of common stock and diluted net loss per share of common stock for the years ended December 31, 2024 and 2023 (in thousands, except share and per share amounts): Year ended December 31, 2024 2023 Net loss $ ( 95,881 ) $ ( 54,698 ) Net loss attributable to common stockholders $ ( 95,881 ) $ ( 54,698 ) Undistributed earnings and net loss attributable to common stockholders, basic and diluted $ ( 95,881 ) $ ( 54,698 ) Weighted-average common shares outstanding, basic and diluted 198,191,936 165,204,652 Basic and diluted net loss per share $ ( 0.48 ) $ ( 0.33 ) 15. Employee Benefits The Company offers a defined contribution 401(k) plan for its employees. Employees are eligible to participate in the plan beginning on the first day following the three month anniversary date of hire. Under the terms of the plan, employees may make voluntary contributions as a percent of compensation. The Company makes discretionary contributions to the 401(k) plan equal to 100 percent of each employee’s pretax contributions up to the IRS annual contribution limit. The Company’s total contributions to the 401(k) plan were $ 0.6 million and $ 0.5 million for the years ended December 31, 2024 and 2023 , respectively. 16. Subs equent Events The Company has evaluated subsequent events through the date these consolidated financial statements were issued. The Company determined there were no events, other than as described below, that required disclosure or recognition in these condensed consolidated financial statements. Loan Agreement On March 26, 2025 (the “Closing Date”), the Company, as borrower, entered into a Loan and Security Agreement (the “Hercules Loan Agreement”) with the lenders party thereto (the “Lenders”) and Hercules Capital, Inc., as administrative agent and collateral agent (the “Agent”). The Hercules Loan Agreement provides for the Company to borrow up to $200 million of term loans (the “Term Loan”). F- 25 The initial advance of $30 million under the Hercules Loan Agreement was drawn on the Closing Date and used to repay all outstanding obligations under the Company’s prior term loan with Silicon Valley Bank, described in Footnote 7. Debt Facility , to pay the Company’s expenses in connection with the Hercules Loan Agreement, and for general corporate purposes. The Company may draw further Term Loans in the following tranches: (i) subject to FDA approval of the Company’s MOLBREEVI product candidate for the treatment of aPAP (the “Approval Milestone”), (a) up to $40 million on or prior to March 15, 2026 and (b) up to $40 million on or prior to December 15, 2026; (ii) subject to the Company achieving a trailing six months net product revenue from the sale of MOLBREEVI of at least seventy-five percent of an agreed upon revenue plan for any reporting period following March 31, 2027 (the “Revenue Milestone”), up to $20 million on or prior to December 31, 2027; and (iii) subject to approval by the Lenders’ investment committees, up to $70 million. The Term Loan will mature April 1, 2030 (the “Maturity Date”). The Term Loan bears interest at a floating rate equal to (i) the greater of (a) the prime rate reported in The Wall Street Journal or (b) 6.0%, plus (ii) 1.45%, or, subject to the Company meeting the Revenue Milestone, 1.20% after the full fiscal quarter following such achievement. The Term Loan has an interest-only monthly payment through March 2028 (the “Interest-Only Period”), and beginning April 1, 2028, requires equal monthly installments of principal plus interest until the Maturity Date. If the Company achieves the Approval Milestone, the Interest-Only period will extend until the Maturity Date. The Company's obligations under the Hercules Loan Agreement are secured, subject to customary permitted liens and other agreed-upon exceptions, by a first-priority perfected security interest in all of the tangible and intangible assets of the Company, other than intellectual property, on which there is a negative pledge. The Hercules Loan Agreement includes customary affirmative and negative covenants, repayment and prepayment terms, representations and warranties, and events of default. The Hercules Loan Agreement contains an affirmative covenant requiring the Company to maintain unrestricted cash under an account control agreement equal to 50% of the outstanding principal of the Term Loan beginning April 1, 2026 (the “Cash Requirement”), which will decrease to 35% upon achievement of the Revenue Milestone and compliance with the Conditional Minimum Revenue Covenant (defined below). However, if the Approval Milestone has not been achieved, the Cash Requirement increases to 70% of the outstanding principal until the Approval Milestone is achieved. Notwithstanding the foregoing, the Cash Requirement will not apply during any period when the Company’s market capitalization exceeds $600 million. Additionally, if the Company draws more than $50 million under the Term Loan, beginning nine months after achievement of the Approval Milestone, the Company will be required to have achieved, and to maintain, trailing six months of net product revenue of at least (i) 65% of a provided sales forecast or (ii) $100 million (“Conditional Minimum Revenue Covenant”). If the Company raises at least $75 million in net cash proceeds from the issuance of equity and/or upfront business development proceeds before June 30, 2026, the Conditional Minimum Revenue Covenant will not apply until 15 months after achievement of the Approval Milestone. Notwithstanding the foregoing, the Conditional Minimum Revenue Covenant will not apply during any period when the Company’s market capitalization exceeds $500 million and the Company maintains minimum unrestricted cash under an account control agreement equal to 50% of the outstanding principal amount of the Term Loan. F- 26