Item 9A. Controls and Procedures
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, 2025, 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, 2025, 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,
58
management concluded that our internal control over financial reporting was effective as of December 31, 2025 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, 2025.
Changes in Internal Control Over Financial Reporting
There were no changes in our internal control over financial reporting that occurred during the quarter ended December 31, 2025 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 adopted, modified or terminated by our executive officers and directors the quarter ended December 31, 2025, each of which was entered into during an open trading window and is intended to satisfy the affirmative defense conditions of of Exchange Act Rule 10b5-1(c) or any non-Rule 10b5-1 trading arrangement as defined in 17 CFR § 229.408(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)
David Ramsay
Member of the Board of Directors
12/18/2025
12/18/2025
12/31/2026
400,000
N/A
(1) A Trading Plan may expire on an earlier date if all contemplated transactions are completed before such Trading Plan’s expiration date, upon termination by broker or the holder of the Trading Plan, or as otherwise provided in the Trading Plan.
Item 9C. Disclosure Regarding Foreign Jurisdictions that Prevent Inspections.
Not applicable
59
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 2026 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, 2025, 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):
• Amended and Restated 2015 Omnibus Incentive Plan (the “2015 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
2008 Plan (2)
127,612
$
1.60
—
2015 Plan (3)
6,616,163
$
2.60
—
2024 Plan (4)
10,120,937
$
3.39
3,134,152
Equity compensation plans
not approved by security holders
2021 Inducement Plan (5)
3,283,750
$
2.59
1,098,321
Total
20,148,462
4,232,473
(1) The weighted average exercise price does not take into account the shares issuable upon vesting of outstanding RSUs, which have no exercise price.
(2) Represents shares issuable upon the exercise of outstanding options granted under the 2008 Plan.
60
(3) Represents shares issuable upon the exercise of outstanding options granted under the 2015 Plan.
(4) Includes 3,868,937 shares issuable upon the exercise of outstanding options granted under the 2024 Plan and 6,252,000 shares issuable upon the vesting of RSUs granted under the 2024 Plan.
(5) Includes 2,630,750 shares issuable upon the exercise of outstanding options granted under the 2021 Inducement Plan and 653,000 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.
61
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, 2025 and 2024
• Consolidated Statements of Operations and Comprehensive Loss for the years ended December 31, 2025 and 2024
• Consolidated Statements of Changes in Stockholders’ Equity for the years ended December 31, 2025 and 2024
• Consolidated Statements of Cash Flows for the years ended December 31, 2025 and 2024
• 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.
62
Exhibit Index
Exhibit Number
Description
3.1
Savara Inc. Amended and Restated Certificate of Incorporation, as amended (Incorporated by reference to Exhibit 3.1 to the Registrant’s Quarterly Report on Form 10-Q filed on November 12, 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.)
63
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.
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).
4.22
*
Form of Pre-Funded Warrant to Purchase Common Stock in October 31, 2025 public offering .
10.1
#
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.)
10.2
#
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.)
10.3
#
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.)
10.4
#
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.)
10.5
#
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.)
10.6
#
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.)
10.7
#
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.)
10.8
#
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.)
10.9
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.)
10.10
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.)
10.11
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.)
10.12
#
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.)
10.13
+
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.)
10.14
+
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.)
10.15
+
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.)
10.16
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.)
10.17
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.)
64
10.18
+
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.)
10.19
+
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.)
10.20
+
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.)
10.21
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.)
10.22
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.)
10.23
+
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.)
10.24
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.)
10.25
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.)
10.26
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.)
10.27
+
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.)
10.28
+
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.)
10.29
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).
10.30
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).
10.31
#
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.)
10.32
#
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.)
10.33
#
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.)
10.34
Executive Employment Agreement, dated October 15, 2024, between Savara Inc. and Braden Parker. (Incorporated by reference to Exhibit 10.38 to the Registrant’s Annual Report on Form 10-K filed on March 27, 2025.)
10.35
Executive Employment Agreement, dated August 24, 2023, between Savara Inc. and Anne Erickson. (Incorporated by reference to Exhibit 10.39 to the Registrant’s Annual Report on Form 10-K filed on March 27, 2025.)
10.36
Amended and Restated Executive Employment Agreement, dated March 13, 2025, between Savara Inc. and Kathleen McCabe. (Incorporated by reference to Exhibit 10.40 to the Registrant’s Annual Report on Form 10-K filed on March 27, 2025.)
10.37
+
Master Services Agreement by and between Savara ApS and Selvita S.A., effective January 17, 2024 (Incorporated by reference to Exhibit 10.41 to the Registrant’s Annual Report on Form 10-K filed on March 27, 2025.)
10.38
Loan and Security Agreement, dated March 26, 2025, between the Company and the lenders party thereto and Hercules Capital, Inc., as administrative agent and collateral agent. (Incorporated by reference to Exhibit 10.1 of the Registrant's Quarterly Report on Form 10-Q filed on May 13, 2025.)
65
10.39
*,#
Purchase and Sales Agreement By and Between Savara Inc. and 4010 Royalty Investments ICAV, an Umbrella Irish Collective Asset-Management Vehicle with Segregated Liability Between Sub-Funds, for and behalf of its Sub-Fund, 4010 Royalty Investments Fund 1, dated October 29, 2025.
10.40
*
Executive Employment Agreement, dated December 9, 2025, between Savara Inc. and Yasmine Wasfi.
10.41
*,#
First Amendment, dated January 26, 2025, to the Loan and Security Agreement March 26, 2025, between the Company and the lenders party thereto and Hercules Capital, Inc., as administrative agent and collateral agent.
10.42
Underwriting Agreement, dated October 29, 2025, by and among Savara Inc., Jefferies LLC and Piper Sandler & Co., as representatives of the several underwriters named therein (incorporated by reference to Exhibit 1.1 of the Registrant’s Current Report on Form 8-K filed on October 30, 2025).
19.1
Insider Trading and Disclosure Policy. (Incorporated by reference to Exhibit 19.1 to the Registrant’s Annual Report on Form 10-K/A filed on April 25, 2025.)
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 67 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
+
Certain portions of this exhibit have been redacted pursuant to Item 601(b)(10) of Regulation S-K.
*
Filed herewith.
**
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.
66
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 13, 2026
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 13, 2026
Matthew Pauls
/s/ Dave Lowrance
Chief Financial and Administrative Officer
(Principal Financial and Accounting Officer)
March 13, 2026
Dave Lowrance
/s/ David Ramsay
Director
March 13, 2026
David Ramsay
/s/ Joseph McCracken
Director
March 13, 2026
Joseph McCracken
/s/ Nevan Elam
Director
March 13, 2026
Nevan Elam
/s/ Rick Hawkins
Director
March 13, 2026
Rick Hawkins
/s/ An Van Es-Johansson
Director
March 13, 2026
An Van Es-Johansson
67
INDEX TO CONSOLIDATED FINANCIAL STATEMENTS
Report of Independent Registered Public Accounting Firm (PCAOB ID: 49 )
F- 2
Consolidated Balance Sheets as of December 31, 2025 and 2024
F- 4
Consolidated Statements of Operations and Comprehensive Loss for the years ended December 31, 2025 and 2024
F- 5
Consolidated Statements of Changes in Stockholders’ Equity for the years ended December 31, 2025 and 2024
F- 6
Consolidated Statements of Cash Flows for the years ended December 31, 2025 and 2024
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, 2025 and 2024, 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, 2025 and 2024, 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 consolidated 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 consolidated 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 consolidated financial statements, taken as a whole, and we are not, by communicating the critical audit matter below, providing a separate opinion on the critical audit matter or on the accounts or disclosures to which it relates.
Research and Development Costs
As described in Note 2 to the financial statements, the Company records expenses of research and development activities, including nonclinical studies, 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 analysis to determine expenses based on the progress made against benchmarks including but not limited to patients enrolled, services performed, and equipment purchased.
During 2025, the Company incurred $81.4 million of research and development expenses. The Company recorded an accrued liability of $6.4 million for expenses incurred but not yet invoiced, and a prepaid expense of $3.2 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 13, 2026
F- 3
Savara Inc. and Subsidiaries
Consolidated Ba lance Sheets
(in thousands, except for share and per share amounts)
As of December 31,
2025
2024
Assets
Current assets:
Cash and cash equivalents
$
33,180
$
15,128
Short-term investments
202,522
181,199
Prepaid expenses and other current assets
5,914
5,808
Total current assets
241,616
202,135
Property and equipment, net
100
165
In-process R&D
11,636
10,337
Other non-current assets
84
242
Total assets
$
253,436
$
212,879
Liabilities and stockholders’ equity
Current liabilities:
Accounts payable
$
5,757
$
4,545
Accrued expenses and other current liabilities
14,639
10,179
Total current liabilities
20,396
14,724
Long-term liabilities:
Long-term debt
29,907
26,619
Other long-term liabilities
—
87
Total liabilities
50,303
41,430
Commitments and contingencies (Note 10)
Stockholders’ equity:
Common stock, $ 0.001 par value, 300,000,000 shares authorized as of
December 31, 2025 and 2024; 204,567,283 and 172,423,223 shares issued
and outstanding as of December 31, 2025 and 2024, respectively
204
173
Additional paid-in capital
811,103
661,276
Accumulated other comprehensive loss
( 87
)
( 750
)
Accumulated deficit
( 608,087
)
( 489,250
)
Total stockholders' equity
203,133
171,449
Total liabilities and stockholders' equity
$
253,436
$
212,879
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,
2025
2024
Operating expenses:
Research and development
$
81,404
$
78,029
General and administrative
42,056
25,037
Depreciation and amortization
87
130
Total operating expenses
123,547
103,196
Loss from operations
( 123,547
)
( 103,196
)
Other income, net:
Interest income, net
4,162
6,467
Foreign currency exchange gain
310
51
Tax credit income
784
797
Loss on extinguishment of debt
( 546
)
—
Total other income, net
4,710
7,315
Net loss
$
( 118,837
)
$
( 95,881
)
Net loss per share:
Basic and diluted
$
( 0.53
)
$
( 0.48
)
Weighted-average common shares outstanding:
Basic and diluted
222,387,531
198,191,936
Other comprehensive income (loss):
Gain (loss) on foreign currency translation
665
( 523
)
Unrealized gain (loss) on short-term investments
( 2
)
44
Total comprehensive loss
$
( 118,174
)
$
( 96,360
)
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, 2025 and 2024
(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, 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
Issuance of common stock and pre-funded warrants in
underwritten public offering, net of offering cost
28,452,381
28
140,200
—
—
140,228
Issuance of common stock upon exercise of pre-funded
warrants
2,165,021
2
—
—
—
2
Issuance of common stock upon exercise
of stock options
190,686
—
347
—
—
347
Issuance of common stock for settlement of RSUs
2,148,000
1
( 1
)
—
—
—
Repurchase of shares for minimum tax withholdings
( 812,028
)
—
( 5,140
)
—
—
( 5,140
)
Stock-based compensation
—
—
14,421
—
—
14,421
Foreign exchange translation adjustment
—
—
—
—
665
665
Unrealized gain on short-term investments
—
—
—
—
( 2
)
( 2
)
Net loss
—
—
—
( 118,837
)
—
( 118,837
)
Balance on December 31, 2025
204,567,283
$
204
$
811,103
$
( 608,087
)
$
( 87
)
$
203,133
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,
2025
2024
Cash flows from operating activities:
Net loss
$
( 118,837
)
$
( 95,881
)
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation and amortization
87
130
Reduction in the carrying value of right-of-use assets
158
145
Amortization of debt issuance costs
453
271
Loss on extinguishment of debt
546
Accretion on discount to short-term investments
( 2,866
)
( 5,442
)
Stock-based compensation
14,421
9,860
Changes in operating assets and liabilities:
Prepaid expenses and other current assets
97
( 2,383
)
Non-current assets
98
11
Accounts payable and accrued expenses and other current liabilities
4,806
4,201
Net cash used in operating activities
( 101,037
)
( 89,088
)
Cash flows from investing activities:
Purchase of property and equipment
( 22
)
( 25
)
Purchase of available-for-sale securities, net
( 204,899
)
( 204,916
)
Maturity of available-for-sale securities
182,200
165,000
Sale of available-for-sale securities, net
4,281
—
Net cash used in investing activities
( 18,440
)
( 39,941
)
Cash flows from financing activities:
Repayment of long-term debt
( 27,229
)
—
Proceeds from long-term debt, net
29,598
—
Issuance of common stock issued in underwritten offering, net of offering costs
140,228
93,798
Issuance of common stock upon exercise of prefunded warrants
2
7
Issuance of common stock upon at the market offerings, net
—
24,374
Proceeds from exercise of stock options
347
347
Reimbursement of commissions from the prior issuance of common stock upon
at the market sales, net
—
46
Repurchase of shares for minimum tax withholdings
( 5,140
)
( 995
)
Net cash provided by financing activities
137,806
117,577
Effect of exchange rate changes on cash and cash equivalents
( 277
)
( 5
)
Increase (decrease) in cash and cash equivalents
18,052
( 11,457
)
Cash and cash equivalents beginning of period
15,128
26,585
Cash and cash equivalents end of period
$
33,180
$
15,128
Supplemental disclosure of cash flow information:
Cash paid for interest
$
3,201
$
2,124
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 (“autoimmune PAP”). 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, 2025, the Company had an accumulated deficit of approximately $ 608.1 million . The Company used cash from operations of approximately $ 101.0 million for the year ended December 31, 2025. 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 autoimmune PAP 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 $ 33.2 million and short-term investments of $ 202.5 million as of December 31, 2025, 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, 2025. The Company may continue to raise additional capital as needed through the issuance of additional equity securities and 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 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 Accounting Standards Update ("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.
F- 9
The Company accrues for expenses resulting from obligations under agreements with contract research organizations (“CROs”), contract manufacturing organizations (“CMOs”), and other outside service providers for which payment flows do not match the periods over which materials or services are provided to the Company. Accruals are recorded based on estimates of services received and efforts expended pursuant to agreements established with CROs, CMOs, and other outside service providers. These estimates are typically based on contracted amounts applied to the proportion of work performed and determined through analysis with internal personnel and external service providers as to the progress or stage of completion of the services. The Company makes significant judgments and estimates in determining the accrual balance in each reporting period. In the event advance payments are made to a CRO, CMO, or outside service provider, the payments will be recorded as a prepaid asset which will be amortized or expensed as the contracted services are performed. As actual costs become known, the Company adjusts its prepaids and accruals. Inputs, such as the services performed, the number of patients enrolled, or the trial duration, may vary from the Company’s estimates, resulting in adjustments to research and development expense in future periods. Changes in these estimates that result in material changes to the Company’s accruals could materially affect the Company’s results of operations. To date, the Company has not experienced any material deviations between accrued and actual research and development expenses. Refer to Note 4. Accrued Expenses and Other Current Liabilities for additional discussion.
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 Accounting Standards Codification ("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, Accounting Standards Update ("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 .
F- 10
If the associated research and development effort is abandoned, the related asset will be written-off, and the Company will record a non-cash impairment loss on its consolidated statements of operations and comprehensive loss. For those products that reach commercialization, the IPR&D asset will be amortized over its estimated useful life. Refer to Note 8. Fair Value Measurements – Assets and Liabilities Measured at Fair Value on a Nonrecurring Basis for additional discussion.
Leases
The Company accounts for a contract as a lease when it has the right to control the asset for a period of time while obtaining substantially all of the asset's economic benefits in accordance with ASU 2016-02, Leases (Topic 842), as codified in ASC 842, Leases . Lease right-of-use assets and liabilities are initially recorded on the lease commencement date based on the present value of lease payments over the lease term. The present value of lease payments is determined by using the interest rate implicit in the lease, if that rate is readily determinable; otherwise, the Company uses its estimated secured incremental borrowing rate for that lease term. Leases may include renewal, purchase, or termination options that can extend or shorten the term of the lease. The exercise of those options is at the Company's sole discretion and is evaluated at inception and throughout the contract to determine if a modification of the lease term is required.
In addition to rent, the leases may require the Company to pay additional amounts for taxes, insurance, maintenance, and other expenses, which are generally referred to as non-lease components. The Company has elected to not separate lease and non-lease components. Only the fixed costs for lease components and their associated non-lease components are accounted for as a single lease component and recognized as part of a right-of-use asset and liability. Rent expense is recognized on a straight-line basis over the reasonably assured lease term based on the total lease payments and is included in operating expenses in the consolidated statements of operations and comprehensive loss.
The Company has made an accounting policy election providing that leases with an initial term of 12 months or less are not recorded as a lease right-of-use asset and corresponding liability in accordance with ASC 842, Leases ; those lease payments are recognized in the consolidated statements of operations and comprehensive loss on a straight-line basis over the lease term. Refer to Note 10. Commitments – Operating Leases for additional discussion.
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.
F- 11
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 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.
Recently Adopted Accounting Pronouncements
In December 2023, the FASB issued ASU 2023-09 (Topic 740), Income Taxes—Improvements to Income Tax Disclosures ("ASU 2023-09") , in order to enhance the transparency and decision usefulness of income tax disclosures. ASU 2023-09 requires greater disaggregation of income tax disclosures related to the income tax rate reconciliation and income taxes paid. The Company adopted this new standard for the year ended December 31, 2025 . These amendments have been applied on a prospective basis in the financial statements. The required disclosure enhancements of ASU 2023-09 did not have a material impact on the Company's consolidated financial statements. See Note 12. Income Taxes for further details.
Recent Accounting Pronouncements (Not Yet Adopted)
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,
2025
2024
Prepaid contracted research and development costs
$
3,159
$
4,179
R&D tax credit receivable
864
768
VAT receivable
390
275
Prepaid insurance
215
131
Royalty purchase and sale agreement derivative
394
—
Deposits and other
892
455
Total prepaid expenses and other current assets
$
5,914
$
5,808
Prepaid Contracted Research and Development Costs
As of December 31, 2025, 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 autoimmune PAP 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, 2025 . 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, 2024, the Company generated a Danish R&D tax credit receivable of $ 0.8 million which was received in the fourth quarter of 2025. During the year ended December 31, 2025 , the Company generated a Danish R&D tax credit receivable of $ 0.9 million which is expected to be received in the fourth quarter of 2026.
4. Accrued Expenses and Other Current Liabilities
Accrued expenses and other liabilities, consisted of (in thousands):
December 31,
2025
2024
Accrued compensation
$
6,552
$
5,017
Accrued contracted research and development costs
6,380
3,912
Accrued general and administrative costs
1,338
1,134
Royalty agreement derivative liability
362
—
Lease liability
7
116
Total accrued expenses and other current liabilities
$
14,639
$
10,179
Accrued Compensation
As of December 31, 2025, 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, 2025, Accrued contracted research and development costs are primarily comprised of costs associated with MOLBREEVI for the treatment of autoimmune PAP, 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, 2025
Amortized Cost
Gross Unrealized Gains
Gross Unrealized Losses
Fair Value
Short-term investments
U.S. government securities
$
202,290
$
232
$
—
$
202,522
Total short-term investments
$
202,290
$
232
$
—
$
202,522
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
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, 2025 and 2024 .
6. Property and Equipment, Net
Property and equipment, net consisted of (in thousands):
December 31,
2025
2024
Research and development equipment
$
1,102
$
1,102
Equipment
878
772
Furniture and fixtures
120
120
Leasehold improvements
333
333
Total property and equipment
2,433
2,327
Less accumulated depreciation
( 2,333
)
( 2,162
)
Property and equipment, net
$
100
$
165
Depreciation expense for the years ended December 31, 2025 and 2024 was minimal.
7. Debt Facility
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 Hercules Loan Agreement provides for the Company to borrow up to $ 200 million of term loans (the “Term Loan”) that may be advanced in multiple tranches.
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 ("SVB Loan"), to pay the Company’s expenses in connection with the Hercules Loan Agreement, and for general corporate purposes. The Hercules Loan Agreement provides t he Company may make further draws in the following tranches: (i) subject to FDA approval of the Company’s MOLBREEVI product candidate for the treatment of autoimmune PAP (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.
F- 14
The Term Loan will mature April 1, 2030 (the “Maturity Date”). Amounts outstanding under the Term Loan bear 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, a 25 bps reduction in the interest rate 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 terms, prepayment terms subject to a 1.0 % or 2.0 % penalty of the amount prepaid as determined when payment occurs following the Closing Date, a contingent prepayment requirement, with any prepayment penalties waived, upon the acquisition or change of control of the Company as defined within the Hercules Loan Agreement, representations and warranties, and events of default, consisting of some events not related to the creditworthiness of the Company, which if triggered, permit the Lenders to accelerate repayment of any outstanding loan amount at the Lenders' discretion. In the event any payment is not paid on the scheduled payment date or upon an aforementioned non-creditworthiness event of default, which may trigger a call feature by the Lenders, an amount equal to 4.0 % of such past due amount shall be payable on demand (collectively, the "Default Penalty").
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.
The Company is obligated to pay customary closing fees, a facility charge equal to 0.5 % of the initial tranche at the Closing Date and upon any additional tranches drawn by the Company during the term of the Hercules Loan Agreement, and an end of term charge based upon the outstanding principal balance equal to 3.95 % if repayment occurs within 24 months of the Closing Date, 4.95 % if repayment occurs after 24 months and before 36 months of the Closing Date, 5.95 % if repayment occurs after 36 months and before 48 months of the Closing Date, and 6.95 % if repayment occurs after 48 months from the Closing Date.
As of December 31, 2025, approximately $ 0.4 million of fees consisting of legal, commitment and facility charges, paid to the Lenders were capitalized and will be amortized over the term of the Hercules Loan Agreement.
The Company has identified certain embedded features within the Hercules Loan Agreement. The Company assessed these features and determined the one feature related to Default Penalty interest due upon an event of default is required to be bifurcated from the debt and accounted for separately at fair value. As of December 31, 2025, the Default Penalty does not have a discernable fair value and no amounts are recorded.
The Company accounted for the repayment of the SVB Loan as an extinguishment in accordance with the guidance in ASC 470-50 and recognized a loss associated with the extinguishment of approximately $ 0.5 million in other income(expense) in the accompanying consolidated statements of operations and comprehensive loss for the twelve months ended the year ended December 31, 2025.
On January 26, 2026, the “Company entered into a First Amendment (the “First Amendment”) to the Hercules Loan Agreement, with Lenders and Hercules Capital, Inc., as administrative agent and collateral agent. As amended, the Loan Agreement provides for the Company to borrow up to an aggregate of $ 105 million of term loans.
F- 15
The First Amendment reset the timing and conditions to the Company’s ability to draw up to $ 75 million of additional term loans under the Hercules Loan Agreement, subject in each case to achievement of the Approval Milestone.
Pursuant to the First Amendment, upon achievement of the Approval Milestone, the Company may borrow up to $ 75 million of additional term loans under the Hercules Loan Agreement, as amended, as follows:
• Up to $ 45 million through the earlier of (i) 120 days following the Approval Milestone or (ii) June 30, 2027 (the “First Post-Approval Tranche”).
• Beginning upon the earlier of the full draw or expiration of the First Post-Approval Tranche, up to $ 30 million through the earlier of (i) 120 days following the Approval Milestone or (ii) June 30, 2027.
Refer to Note 16. Subsequent Events in the notes to our consolidated financial statements in this annual report on Form 10-K for additional discussion.
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,
2026
$
—
2027
—
2028
11,297
2029
14,747
2030
6,041
Total future minimum payments
32,085
Unamortized end of term charge
( 1,767
)
Debt fees
( 411
)
Total debt
29,907
Current portion of long-term debt
—
Long-term debt
$
29,907
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 categorizes its financial assets and liabilities measured and reported at fair value in the financial statements on a recurring basis based upon the level of judgment associated with the inputs used to measure their fair value. Hierarchical levels, which are directly related to the amount of subjectivity associated with the inputs used to determine the fair value of financial assets and liabilities, are as follows:
• Level 1—Inputs are unadjusted, quoted prices in active markets for identical assets or liabilities at the measurement date.
• Level 2—Inputs (other than quoted prices included in Level 1) are either directly or indirectly observable for the assets or liability through correlation with market data at the measurement date and for the duration of the instrument’s anticipated life
• Level 3—Inputs reflect management’s best estimate of what market participants would use in pricing the asset or liability at the measurement date. Consideration is given to the risk inherent in the valuation technique and the risk inherent in the inputs to the model.
Each major category of financial assets and liabilities measured at fair value on a recurring basis is categorized based upon the lowest level of significant input to the valuations. The fair value hierarchy also requires an entity to maximize the use of observable inputs and minimize the use of unobservable inputs when measuring fair value. The Company determined that certain investments in debt securities classified as available-for-sale securities were Level 1 financial instruments.
F- 16
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, 2025 and 2024 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, 2025
Cash equivalents:
U.S. Treasury money market funds
$
32,210
$
—
$
—
$
32,210
Short-term investments:
U.S. government securities
202,522
—
—
202,522
Current liabilities:
Royalty purchase and sale agreement derivative
—
—
362
362
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
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, 2025 and 2024.
Royalty Purchase and Sale Agreement Derivative Liability
The derivative liability arose from the royalty purchase and sale agreement entered on October 29, 2025, as further described in Note 10. Commitments , under which the seller has the option to prepay the buyer and the buyer may require the seller to remunerate proceeds of $ 4.0 million upon a change of control, as further defined, prior to approval of MOLBREEVI by the FDA on or before March 31, 2027. The fair value of the derivative liability is estimated utilizing a probability-adjusted discounted cash flow approach and is performed quarterly with gains and losses included within change in fair value of the derivative liability in the consolidated statements of comprehensive loss. This obligation would be settled in cash. As of October 29, 2025 and December 31, 2025, the Company assessed a 20 % probability that a change of control would occur prior to the closing date of the royalty purchase and sale agreement and a 50 % probability that the purchaser would exercise its right to the prepayment, which would terminate the royalty purchase and sale agreement. After taking into consideration the probability of repayment, the time value of money, and the counterparty credit risk, the estimated fair value of the put option derivative liability as $ 363 thousand and $ 362 thousand as of the October 29, 2025 and December 31, 2025 measurement dates, respectively.
The derivative liability has been classified as a Level 3 recurring liability as its valuation requires substantial judgment and estimation of factors that are not currently observable in the market. If different assumptions were used for the inputs to the valuation approach, the estimated fair value could be significantly different than the fair value the Company determined. The derivative liability is expected to either be settled or absolved within twelve months and is therefore classified as a current liability in the consolidated balance sheet.
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, 2025 and 2024, the Company had IPR&D of approximately $ 11.6 million and $ 10.3 million, respectively. For the years ended December 31, 2025 and 2024, the Company experienced an increase of approximately $ 1.3 million and an decrease of approximately $ 0.6 million, respectively, in the carrying value of IPR&D, which was due to foreign currency translation.
F- 17
9. Stockh olders’ Equity
Underwritten Offering of Common Stock
October 2025
On October 31, 2025, the Company sold pursuant to an underwritten public offering (i) an aggregate of 28,452,381 shares of the Company’s common stock for $ 4.20 per share, including 4,642,857 shares of common stock sold pursuant to the exercise in full by the underwriters of their option to purchase additional shares, and (ii) pre-funded warrants to purchase an aggregate of 7,142,857 shares of common stock at an exercise price of $ 0.001 per share (the “2025 Pre-Funded Warrants”) for $ 4.199 per pre-funded warrant (collectively, the “October 2025 Offering”). The October 2025 Offering was offered by the Company pursuant to the 2024 Registration Statement, and a prospectus supplement filed with the SEC on October 30, 2025.
The Company determined that the securities issued in the October 2025 Offering were free-standing and that the 2025 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 October 2025 Offering resulted in net proceeds to the Company of approximately $ 140.2 million, after deducting final underwriting discounts, commissions, and other estimated offering expenses, as follows (in thousands):
Financial instruments
Proceeds
Common stock
$
119.5
2025 Pre-funded warrants
30.0
Total
$
149.5
Estimated offering expenses
( 9.3
)
Net proceeds
$
140.2
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
Evercore Common Stock Sales Agreement Termination
On July 6, 2021, the Company entered into a Sales Agreement with Evercore Group L.L.C. (“Evercore”), as sales agent (the “ATM Agreement”), permitting the Company to offer and sell up to an aggregate of $ 100.0 million of shares of its common stock, par value $ 0.001 per share, from time to time through Evercore in “at the market offerings” as defined in Rule 415 under the Securities Act of 1933, as amended. On March 31, 2025, pursuant to Section 12(b) of the ATM Agreement, the Company delivered written notice to Evercore that it was terminating the ATM Agreement, effective April 2, 2025. The Company is not subject to any termination penalties related to the termination of the ATM Agreement.
During the year ended December 31, 2024, the Company sold 6,038,650 shares of the Company’s common stock to a single institutional investor pursuant to the Sales Agreement resulting in net proceeds of $ 24.4 million. The Company did not sell any shares of common stock under the Sales Agreement d uring the year ended December 31, 2025.
F- 18
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, 2025 and 2024:
December 31
2025
2024
Common stock authorized
300,000,000
300,000,000
Common stock outstanding
204,567,283
172,423,223
The Company’s shares of common stock reserved for issuance as of December 31, 2025 and 2024 were as follows:
December 31,
2025
2024
April 2017 Warrants
24,725
24,725
June 2017 Warrants
41,736
41,736
December 2018 Warrants
11,332
11,332
Pre-funded PIPE Warrants
3,615,516
5,780,537
2021 Pre-funded Warrants
32,175,172
32,175,172
2023 Pre-funded Warrants
5,666,667
5,666,667
2025 Pre-funded Warrants
7,142,857
—
Stock options outstanding
13,243,462
13,554,621
Issued and non-vested RSUs
6,905,000
4,677,500
Total shares reserved
68,826,467
61,932,290
Warrants
The following table summarizes the outstanding warrants for the Company’s common stock as of December 31, 2025:
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
48,600,212
$
0.001
48,678,005
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, 2023
$
( 461
)
$
190
$
( 271
)
Change
( 523
)
44
( 479
)
Balance, December 31, 2024
$
( 984
)
234
$
( 750
)
Change
665
( 2
)
663
Balance, December 31, 2025
$
( 319
)
$
232
$
( 87
)
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
F- 19
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, 2025, the carrying value of the right-of-use assets for the operating lease was approximately $ 0.1 million, which is reflected in Prepaid expenses and other current assets and the carrying value of the lease liabilities for the operating lease experienced a minimal decrease, which is reflected in Accrued expenses and other current 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, 2025 (in thousands):
Year ending December 31,
2026
$
87
Total future minimum lease payments
$
87
Less imputed interest
( 2
)
Total
$
85
Operating cash flows from operating leases
$
175
Weighted-average remaining lease term (in months) - operating leases
6
Weighted-average discount rate - operating leases
7.8
%
Manufacturing and Other Commitments and Contingencies
The Company has entered into a number of contracts for the manufacture of its product candidate, MOLBREEVI. Some of these, as enumerated below entail various royalties and manufacturing and development payments.
FujiFilm Diosynth (“Fuji”)
In February 2024, the Company entered into a master services agreement with Fuji to provide development and manufacturing services related to the active pharmaceutical ingredient (“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 Fuji, in total, estimated fees of $ 44.6 million of which $ 15.6 million and $ 15.9 million has been recognized as expense during the years ended December 31, 2025 and 2024 . Amounts payable for future services 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.
GEMABIOTECH SAU (“GEMA”)
Under a manufacture and supply agreement, as amended, with GEMA related to the API for MOLBREEVI, the Company must make certain payments to GEMA 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 supplied by GEMA 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 GEMA a royalty equal to low-single digits of the net sales in that country.
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 supplied by GEMA in any country, the Company will purchase from GEMA 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 GEMA exceeds a certain price charged by an alternative supplier, (ii) there is a shortage of supply, or (iii) GEMA at any time fails to materially fulfill a purchase order of the Company.
PARI Pharma GmbH (“PARI”)
The Company is also subject to certain contingent milestone payments, disclosed in the table set forth below, payable to PARI, the manufacturer of the proprietary nebulizer used to administer MOLBREEVI. In addition to these milestones, the Company will owe PARI a royalty of three-and one-half percent ( 3.5 %) based on net sales.
F- 20
Milestone Payments
The following table summarizes manufacturing commitments and contingencies as of the period indicated (in thousands):
December 31, 2025
MOLBREEVI manufacturer:
Achievement of certain milestones related to validation of API and regulatory approval of
MOLBREEVI
$
200
MOLBREEVI nebulizer manufacturer:
Achievement of various development activities and regulatory approval of nebulizer
utilized to administer MOLBREEVI
587
Total manufacturing and other commitments
$
787
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, 2025 .
Contract Research
As part of its development of MOLBREEVI for the treatment of autoimmune PAP, the Company entered into a Master Services Agreement (“MSA”) with Parexel International (IRL) Limited (“Parexel”) pursuant to which Parexel provides contract research services related to clinical trials. Contemporaneously with entering the MSA in January 2021, a work order was executed with Parexel, under which they provide services related to the IMPALA-2 trial. From inception of the original work order and subsequent change orders through trial close-out activities, the Company is obligated to pay Parexel service fees, pass-through expenses, and investigator fees estimated to be approximately $ 51.3 million over the course of the IMPALA-2 clinical trial and trial close-out activities of which $ 8.0 million and $ 9.2 million has been recognized as expense during the years ended December 31, 2025 and 2024, respectively.
In the second quarter of 2024, the Company initiated an open-label, multicenter clinical trial of MOLBREEVI in pediatric subjects with autoimmune PAP ("IMPACT") under a separate work order with Parexel. Pursuant to the IMPACT trial, Parexel currently has the opportunity to earn up to approximately $ 5.6 million in various milestone payments primarily dependent upon patient enrollment, site management, project oversight and the compliance with defined study protocols of which $ 1.1 million and 1.3 million was recognized in the years ended December 31, 2025 and 2024, respectively.
Royalty Purchase and Sale Agreement
On October 29, 2025, the Company entered into a purchase and sale agreement (the “Purchase Agreement”) with funds managed by RTW Investments, LP (the “Purchaser”). Under the terms of the Purchase Agreement, the Purchaser has agreed to pay the Company $ 75.0 million (the “Purchase Price”) upon approval of MOLBREEVI by the FDA on or before March 31, 2027 ( the date of such payment, the "Closing Date") and subject to satisfaction of other customary closing conditions, in exchange for a true sale of assigned interests, including the right to receive royalty payments equal to a percentage of Net Sales (as defined in the Purchase Agreement) of MOLBREEVI in the U.S. The royalty rate is tiered, with the payments ranging from 7.0 % to 1.0 % of Net Sales in each calendar year, with the 7.0 % tier increasing to 9.5 % for a calendar year if the prior year’s Net Sales do not achieve a specified level. The royalty payments commence in the first calendar quarter in which there is a commercial sale of MOLBREEVI in the United States and end upon the receipt by the Purchaser of $ 187.5 million (the “Maximum Payment”). The Purchase Agreement includes a buy-back option that may allow the Company to pay a specified amount up to the Maximum Payment to terminate the Purchase Agreement and all obligations in the event of certain changes of control within two years of receipt of the Purchase Price. Unless otherwise agreed with the Purchaser, the Company is required to use a portion of the Purchase Price to repay all outstanding indebtedness. The Purchase Agreement contains customary affirmative and negative covenants, including covenants that limit or restrict the Company’s ability to, among other things, incur indebtedness (which restrictions are eliminated after the achievement by the Company of a specified amount of Net Sales), and other provisions customary for transactions of this nature, in each case subject to certain exceptions set forth in the Purchase Agreement.
Under the Purchase Agreement, upon the occurrence of a Change of Control of the Company (as defined in the Purchase Agreement) the Company has the option to prepay (“Company Call”) and the Purchaser has the option to demand the prepayment (“Buyer Put”) of a specified amount and terminate the Purchase Agreement. The revenue-based repayments to the Buyer (“Revenue-Based Payment”) will be established on a schedule of royalty rates as a factor of Annual Net Sales, including applicable ratchets in the definition of a Royalty Rate, until the Royalty Cap is reached.
The Company has identified the embedded features in the Purchase Agreement and concluded that the Buyer Put Option and the Company Call Option are embedded derivatives that must be bifurcated under ASC 815-10-15-83 and ASC 815-15-25-1, Derivatives and Hedging.
F- 21
Accordingly, the Company has recorded the royalty agreement derivative as of the date of issuance and determined its fair value to be approximately $ 0.4 million as of the issue date and December 31, 2025. The Company has also capitalized the amount as deferred issuance costs, subject to straight line amortization up until the Closing Date, which is reflected in Prepaid expenses and other current assets and recorded a derivative liability reflected in Accrued expenses and other current liabilities, subject to periodic fair value remeasurement
In addition, direct and incremental Company issuance costs as well as reimbursed Buyer expenses have been capitalized by the Company and amortized over the expected term of the arrangement. Upon the Purchase Agreement closing, the remaining balance will be applied against the proceeds received and subsequently amortized using the effective interest method.
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"), which was 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"), Chief Commercial Officer ("CCO") and Chief Legal Officer ("CLO") has entered into an employment agreement with the Company that entitles them to payments and benefits if the CFO, CMO, COO, CBO, CCO or CLO, 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 that would have otherwise vested had the executive remained employed by the Company for an additional 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, CCO or CLO i s 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.
Litigation
On September 8, 2025, a putative securities class action complaint, Ho, et al. v. Savara Inc., et al. , was filed against the Company and certain of our executive officers in the United States District Court for the Eastern District of Pennsylvania. The complaint alleges violations of Sections 10(b) and 20(a) of the Securities Exchange Act of 1934 and Rule 10b-5 promulgated thereunder in connection with various public statements made by the Company regarding its regulatory filings for MOLBREEVI as a therapy to treat patients with autoimmune PAP. The plaintiffs seek unspecified damages, costs and expenses, including attorneys’ fees. On each of December 4, 2025 and January 16, 2026, a stockholder derivative complaint was filed in the United States District Court for the Eastern District of Pennsylvania against our directors, certain of our officers, and the Company as a nominal defendant, Norman v. Pauls, et al. and Lasky v. Pauls, et
F- 22
al. , respectively. The derivative complaints arise out of similar allegations as the securities class action and were consolidated and stayed pending further proceedings in the securities class action. In each of the derivative complaints, the plaintiffs seek changes to the Company’s corporate governance and internal procedures, as well as unspecified monetary damages, costs and expenses, including attorneys’ fees.
On February 6, 2026, the co-lead plaintiffs in the securities class action voluntarily dismissed the action without prejudice as to all defendants. On February 12, 2026, the plaintiffs in the stockholder derivative action voluntarily dismissed the action without prejudice as to all defendants.
From time to time, the Company may be subject to various legal proceedings and claims that arise in the ordinary course of its business activities. Although the results of litigation and claims cannot be predicted with certainty, the Company does not believe it is party to any claim or litigation the outcome of which, if determined adversely to the Company, would individually or in the aggregate be reasonably expected to have a material adverse effect on its business. Regardless of the outcome, litigation can have an adverse impact on the Company because of defense and settlement costs, diversion of management resources, and other factors.
11. Stock -Based Compensation
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 stock units ("PSUs"), 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, 2025, the number of shares of common stock available for grant under the 2024 Plan was 3,134,152 shares.
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, PSUs, 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, 2025, the number of shares of common stock available for grant under the Inducement Plan was 1,098,321 shares.
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, 2025, the Company had options outstanding to purchase 127,612 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 .
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, including PSUs, are valued at the closing market price of the Company’s common stock on the date of grant.
During the year ended December 31, 2025 , the Company granted 4,545,000 PSUs (the “2025 PSUs”) to certain of its employees and non-employee service providers. The 2025 PSUs are subject to certain performance conditions and a service condition. The performance conditions range from (i) FDA approval of the Company’s BLA for MOLBREEVI for the treatment of autoimmune PAP, of which 225,000 PSUs require approval on or before a specified date, (ii) the European Medicines Agency approval of the Company’s marketing authorisation application for MOLBREEVI for the treatment of autoimmune PAP, (iii) the achievement of a certain revenue target, or (iv) a combination of some the aforementioned performance conditions. The service condition is continuous employment or service with the Company through the date
F- 23
the performance obligations may be achieved. The potential payout of the award ranges from 0 % to 100 % of the target, dependent on the achievement of the performance conditions and their respective weighting towards the vesting of the 2025 PSUs as predetermined by the Company. The Company began recognizing and recording compensation cost on a straight-line basis in the consolidated statements of comprehensive loss upon the grant date of the 2025 PSU grants as the performance conditions were deemed probable by the Company. Any forfeitures of unvested awards that occurs after the recognition of compensation cost will result in the cumulative reversal of expense in the period in which the forfeiture occurs.
The following table summarizes the assumptions used for estimating the fair value of stock options granted to employees for the years ended December 31, 2025 and 2024:
2025
2024
Risk-free interest rate
3.67 % - 4.51 %
3.58 % - 4.55 %
Expected term (years)
6.44 - 6.71
6.06 - 9.26
Expected volatility
114.3 %
90.9 % - 114.6 %
Dividend yield
0 %
0 %
Stock-Based Award Activity
The following tables provide a summary for stock option and RSU activity for the year ended December 31, 2025:
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, 2024
13,554,621
$
2.79
7.89
$
11,586
Granted
409,500
3.26
6.06
Exercised
( 192,159
)
1.85
$
324
Expired/cancelled/forfeited
( 528,500
)
1.92
Outstanding at December 31, 2025
13,243,462
$
2.82
6.94
$
46,078
Options exercisable at December 31, 2025
8,364,040
$
2.56
5.99
$
32,198
The weighted-average grant date fair values for the Company’s stock options granted during the years ended December 31, 2025 and 2024 were $ 2.82 per share and $ 3.47 per share, respectively. The total compensation cost related to non-vested stock options not yet recognized as of December 31, 2025 was $ 13.1 million, which will be recognized over a weighted-average period of approximately 2.7 years.
During the years ended December 31, 2025 and 2024 , 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, 2025 and 2024, respectively.
RSUs:
Shares
Underlying
Stock Awards
Weighted-Average Grant Date Fair Value
Outstanding at December 31, 2024
4,677,500
$
3.83
Granted
5,080,500
6.11
Vested
( 2,148,000
)
4.03
Expired/cancelled/forfeited
( 545,000
)
—
Vested and deferred settlement
( 160,000
)
3.35
Outstanding at December 31, 2025
6,905,000
$
5.40
RSUs with deferred settlement are considered equity-classified awards as the Company does not have an obligation to settle the awards in cash and the participant cannot accelerate settlement. The Company recognizes compensation expense on a straight-line basis over the requisite service period based on the grant-date fair value of the awards. As of December 31, 2025 , the Company had 160,000 vested RSUs with deferred settlement outstanding, representing deferred shares to be issued in future periods. These shares are reflected as issued and outstanding for accounting purposes only upon physical delivery of the shares. The total compensation cost related to unvested RSUs not yet recognized as of December 31, 2025 was $ 32.1 million, which will be recognized over a weighted-average period of 1.9 years.
F- 24
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, 2025 and 2024 (in thousands):
Year ended December 31,
2025
2024
Research and development
$
4,055
$
4,453
General and administrative
10,366
5,407
Total stock-based compensation
$
14,421
$
9,860
12. Inc ome Taxes
The components of loss before income taxes for the years ended December 31, 2025 and 2024 are as follows (in thousands):
December 31,
2025
2024
Domestic
$
( 84,300
)
$
( 63,256
)
Foreign
( 34,537
)
( 32,625
)
Total
$
( 118,837
)
$
( 95,881
)
The Company did no t record a federal tax benefit or expense for the years ended December 31, 2025 and 2024. 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, 2025 due to revenues below the minimum tax threshold. The components of the income tax expense are as follows for the years ended December 31, 2025 and 2024 (in thousands):
December 31,
2025
2024
Current:
Federal
$
—
$
—
State
—
9
Foreign
—
—
Total Current
—
9
Deferred:
Federal
—
—
State
—
—
Foreign
—
—
Total Deferred
—
—
Total income tax expense
$
—
$
9
F- 25
As noted above, we adopted ASU 2023-09 on a prospective basis effective January 1, 2025. The following table presents required disclosure pursuant to ASU 2023-09 and reconciles the U.S. federal statutory tax amount and rate to our actual global effective amount and rate for the year ended December 31, 2025:
December 31, 2025
Federal
$
( 24,956
)
21.00
%
Other States
—
0.00
%
Foreign
Income taxes, net of amounts refunded
Statutory tax rate difference between DK and US
( 345
)
0.29
%
Change in valuation allowance
6,968
- 5.86
%
Other
630
- 0.53
%
Tax credits
Orphan drug tax credit
( 8,033
)
6.76
%
Change in valuation allowance
23,375
- 19.67
%
Nontaxable or Nondeductible Items
Imputed Interest Income
1,810
- 1.52
%
162(m) Limitation
1,150
- 0.97
%
Other
( 604
)
0.50
%
Other adjustments
Other
5
0.00
%
Total
$
—
0.00
%
(a) The company does not have any state income tax in current year.
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 year ended December 31, 2024 (in thousands):
December 31, 2024
Income tax benefit computed at federal statutory tax rate
$
( 20,135
)
State taxes, net of federal
7
Change in valuation allowance
29,911
Orphan drug & research credits generated
( 9,659
)
Impact of foreign operations
( 338
)
Foreign deferred tax asset - true up
( 750
)
Actualization and deferred tax asset - true up
( 214
)
Imputed interest
1,498
Permanent differences
( 311
)
Other
—
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, 2025 and 2024, the valuation allowance increased by $ 35.4 million and $ 33.5 million, respectively.
F- 26
Significant components of the Company’s deferred tax assets and liabilities are as follows (in thousands):
December 31,
2025
2024
Deferred tax liabilities:
ROU assets
$
23
$
67
Other
397
687
Total deferred tax liabilities
420
754
Deferred tax assets:
Net operating loss carryforwards
85,643
58,384
Intangible assets
111
379
Amortization
—
1,263
Credit carryforwards
30,656
22,624
Section 174 research and development expenses
20,007
20,058
ROU liabilities
2
56
Depreciation
315
272
Stock-based compensation
4,448
3,618
Accrued liabilities & other
1,969
1,456
Total deferred tax assets
143,151
108,110
Subtotal
142,731
107,356
Valuation allowance
( 142,731
)
( 107,356
)
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, 2025 and 2024, the Company still has $ 53.9 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, 2025 and 2024, the Company had foreign NOL carryforwards of approximately $ 177.1 million and $ 137.7 million, respectively, which have an indefinite carryforward period. After taking the Section 382 limitations discussed into account, as of December 31, 2025 and 2024, the Company had NOLs for federal income tax purposes of approximately $ 195.3 million and $ 126.0 million, respectively. Federal NOL carryforwards of $ 5.2 million begin to expire in 2037 , with $ 190.1 million not having an expiration date. As of December 31, 2025 and 2024, the Company had state NOL carryforwards of approximately $ 96.0 million and $ 25.3 million, respectively. The state NOL carryforwards begin to expire in 2037.
As of December 31, 2025 and 2024, the Company also had available research and orphan drug tax credit carryforwards for federal income tax purposes of approximately $ 30.2 million and $ 22.1 million, respectively. If not utilized, these carryforwards expire at various dates beginning in 2039 . As of December 31, 2025 and 2024, 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.
Law Changes
On July 4, 2025, H.R. 1 – OBBBA, the One Big Beautiful Bill Act (“OBBBA”), was signed into law. Effective beginning in 2025, OBBBA provides for US tax law changes and modifications including the ability to deduct US based research and development expenditures, a more favorable interest expense limitation, the reinstatement of 100% bonus depreciation on qualified property and several changes to the US taxation of foreign activity. Given the Company’s history of net operating losses, OBBBA did not have a significant impact on the Company’s financial statements.
F- 27
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, 2025 and 2024 , the Company had no unrecognized tax benefits. During the years ended December 31, 2025 and 2024 , 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, 2025, 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 2020 and subsequent tax years remain open and subject to examination by the state taxing authorities. The 2021 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.
New Accounting Pronouncement Adoption
We adopted ASU 2023-09 on a prospective basis for the year ended December 31, 2025 and have included the following table as a result of our adoption, which presents income taxes paid (net of refunds received) for the year ended December 31, 2025:
December 31, 2025
Federal
$
—
Other States
—
Foreign
—
Income taxes, net amounts refunded
$
—
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 autoimmune PAP. 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
F- 28
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,
2025
2024
Operating expenses:
Research and development operating costs and expenses excluding
non-cash stock-based compensation:
Primary program research and development expenses (a)
$
61,744
$
59,325
Other research and development expenses:
Payroll and benefits
13,549
11,933
Occupancy and other overhead and operating costs
2,056
2,318
Total other research and development expenses
15,605
14,251
Research and development operating costs and expenses excluding
non-cash stock-based compensation:
77,349
73,576
General and administrative expense excluding non-cash stock-based
compensation
31,690
19,630
Other segment income (expense), net (b)
9,798
2,675
Segment net loss
$
( 118,837
)
$
( 95,881
)
(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.
(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, loss on extinguishment of debt (for the year ended December 31, 2025) 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, 2025 and 2024, potentially dilutive securities include:
Year ended December 31,
2025
2024
Awards under equity incentive plan
13,243,462
13,554,621
Non-vested restricted shares and restricted stock units
6,905,000
4,677,500
Warrants to purchase common stock
77,793
77,793
Total
20,226,255
18,309,914
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, 2025 and 2024 (in thousands, except share and per share amounts):
Year ended December 31,
2025
2024
Net loss
$
( 118,837
)
$
( 95,881
)
Net loss attributable to common stockholders
$
( 118,837
)
$
( 95,881
)
Undistributed earnings and net loss attributable to
common stockholders, basic and diluted
$
( 118,837
)
$
( 95,881
)
Weighted-average common shares outstanding, basic
and diluted
222,387,531
198,191,936
Basic and diluted net loss per share
$
( 0.53
)
$
( 0.48
)
F- 29
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 ninety days of the 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 eighteen thousand dollars. The Company’s total contributions to the 401(k) plan were $ 0.9 million and $ 0.6 million for the years ended December 31, 2025 and 2024 , 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 January 26, 2026, the Company entered into a First Amendment (the “First Amendment”) to the Hercules Loan Agreement as described in Note 7. Debt Facility , with the Lenders. As amended, the Hercules Loan Agreement provides for the Company to borrow up to an aggregate of $ 105 million of term loans.
The First Amendment reset the timing and conditions to the Company’s ability to draw up to $ 75 million of additional term loans under the Hercules Loan Agreement, subject in each case to FDA approval of the Company’s MOLBREEVI product candidate for the treatment of autoimmune PAP (the “Approval Milestone”).
Pursuant to the Hercules Loan Agreement, as amended by the First Amendment, upon achievement of the Approval Milestone, the Company may borrow up to $ 75 million of additional term loans under the Hercules Loan Agreement, as follows:
• Up to $ 45 million through the earlier of (i) 120 days following the Approval Milestone or (ii) June 30, 2027 (the “First Post-Approval Tranche”).
• Beginning upon the earlier of the full draw or expiration of the First Post-Approval Tranche, up to $ 30 million through the earlier of (i) 120 days following the Approval Milestone or (ii) June 30, 2027.
The First Amendment extended the dates by which the Company may be required to comply with two financial covenants, extending the initial date for compliance with the Cash Requirement to April 1, 2027, and the date for compliance with the Conditional Minimum Revenue Covenant to September 30, 2027, if its market capitalization falls below the previously reported thresholds for each respective covenant.
The Hercules Loan Agreement, as amended by the First Amendment, grants the Lenders a first-priority perfected security interest in the Company’s intellectual property that will convert to a negative pledge if the Company terminates the Purchase Agreement dated as of October 29, 2025 with funds managed by the Purchaser, as described in Note 10. Commitments prior to receiving funds under the Purchase Agreement and so long as the Company maintains $ 50 million or more in unrestricted cash.
Litigation
On February 6, 2026, the co-lead plaintiffs of the securities class action claim filed against the Company on September 8, 2025, as described in Note 10. Commitments to our consolidated financial statements in this Annual Report on Form 10-K, voluntarily dismissed the action without prejudice as to all defendants. On February 12, 2026, the plaintiffs in the stockholder derivative action described in Note 10. Commitments to our consolidated financial statements in this Annual Report on Form 10-K voluntarily dismissed the action without prejudice as to all defendants.
New Lease Agreement
On March 10, 2026 , the Company entered into a lease agreement (the “New PA Lease”) for its office headquarters in Yardley, Pennsylvania. The New PA Lease shall commence on July 1, 2026 and continues through November 30, 2031 .
Concurrent with the New PA Lease, the Company is not renewing its current operating lease for its office space in Langhorne Pennsylvania with termination of the Langhorne Pennsylvania lease effective June 30, 2026 .
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