6 unchanged sentences
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”).
−Removed: As a result of that assessment, management concluded that our internal control over financial reporting was effective as of December 31, 2024 based on criteria in Internal Control - Integrated Framework (2013) issued by the COSO.
+Added: As a result of that assessment,
+Added: 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
−Removed: There were no changes in our internal control over financial reporting that occurred during Savara’s quarter ended December 31, 2024 that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.
+Added: 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.
Other Information:
1 unchanged sentence
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.
−Removed: The following table describes the written plans for the sale of our securities terminated by our executive officers and directors during the quarter ended December 31, 2024, each of which was entered into and terminated during an open trading window and was intended to satisfy the affirmative defense conditions of Rule 10b5-1(c) (each, a Trading Plan).
+Added: 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
4 unchanged sentences
Date Plan Terminated (1)
−Removed: Matthew Pauls
−Removed: Chief Executive Officer and Chair of the Board of Directors
−Removed: David Lowrance
−Removed: Chief Financial and Administrative Officer
−Removed: (1) Each Trading Plan was terminated prior to any sales being made pursuant to such Trading Plan.
−Removed: No other Company directors or officers (as defined in Rule 16a-1(f) under the Exchange Act) adopted , modified or terminated a Rule 10b5-1 trading arrangement or a non-Rule 10b5-1 trading arrangement (as defined in Item 408(c) of Regulation S-K) during the quarter ended December 31, 2024.
+Added: Member of the Board of Directors
+Added: (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.
Disclosure Regarding Foreign Jurisdictions that Prevent Inspections.
14 unchanged sentences
provided, however, that new equity awards may only be issued under the 2024 Omnibus Incentive Plan and the 2021 Inducement Plan):
+Added: • Amended and Restated 2015 Omnibus Incentive Plan (the “2015 Plan”)
• 2024 Omnibus Incentive Plan (the “2024 Plan”)
8 unchanged sentences
approved by security holders
+Added: 2008 Plan (2)
+Added: 2015 Plan (3)
+Added: 2024 Plan (4)
Equity compensation plans
not approved by security holders
−Removed: Total (2),(3)
+Added: 2021 Inducement Plan (5)
(1) The weighted average exercise price does not take into account the shares issuable upon vesting of outstanding RSUs, which have no exercise price.
−Removed: (2) Includes 10,766,914 shares issuable upon the exercise of outstanding options granted under the 2024 Plan, 2,648,375 shares issuable upon the exercise of outstanding options granted under the 2021 Inducement Plan, and 139,332 shares issuable upon the exercise of outstanding options granted under the 2008 Plan.
−Removed: (3) Includes 3,750,000 shares issuable upon the vesting of RSUs granted under the 2024 Plan and 927,500 shares issuable upon the vesting of RSUs granted under the 2021 Inducement Plan.
+Added: (2) Represents shares issuable upon the exercise of outstanding options granted under the 2008 Plan.
+Added: (3) Represents shares issuable upon the exercise of outstanding options granted under the 2015 Plan.
+Added: (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.
+Added: (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.
Certain Relationships and Related Transactions, and Director Independence.
25 unchanged sentences
Exhibit Number
−Removed: Certificate of Amendment to Amended and Restated Certificate of Incorporation (Incorporated by reference to Exhibit 3.1 to the Registrant’s Current Report on Form 8-K filed on June 7, 2024).
+Added: 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).
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).
23 unchanged sentences
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.)
−Removed: Description of Registered Securities (Incorporated by reference to Exhibit 4.25 to the Registrant’s Annual Report on Form 10-K filed on March 12, 2020.)
+Added: Description of Registered Securities.
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.)
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).
−Removed: Amended and Restated Loan and Security Agreement, dated April 21, 2022, between the Registrant and its subsidiary, Aravas Inc., as borrowers, and Silicon Valley Bank (Incorporated by reference to Exhibit 10.1 to the Registrant's Quarterly Report on Form 10-Q filed on May 11, 2022.)
+Added: Form of Pre-Funded Warrant to Purchase Common Stock in October 31, 2025 public offering .
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.)
23 unchanged sentences
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.)
−Removed: Sales Agreement, dated July 6, 2021, between the Registrant and Evercore Group L.L.C.
−Removed: (Incorporated by reference to Exhibit 1.2 of the Registrant’s Registration Statement on Form S-3 filed on July 6, 2021.)
Amended and Restated Executive Employment Agreement, dated December 13, 2022, between Savara Inc.
4 unchanged sentences
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.)
−Removed: Executive Employment Agreement, dated November 10, 2022, between Savara Inc.
−Removed: and Raymond D.
−Removed: (Incorporated by reference to Exhibit 10.34 to the Registrant’s Annual Report on Form 10-K filed on March 30, 2023.)
Executive Employment Agreement, dated February 13, 2023, between Savara Inc.
14 unchanged sentences
1) filed on June 10, 2024).
−Removed: 2021 Inducement Equity Incentive Plan, as amended (Incorporated by reference to Exhibit 4.1 to the Registrant’s Registration Statement on Form S-8 filed on October 1, 2024).
Form of Incentive Stock Option Award Agreement under the 2024 Omnibus Incentive Plan.
6 unchanged sentences
and Braden Parker.
+Added: (Incorporated by reference to Exhibit 10.38 to the Registrant’s Annual Report on Form 10-K filed on March 27, 2025.)
Executive Employment Agreement, dated August 24, 2023, between Savara Inc.
and Anne Erickson.
+Added: (Incorporated by reference to Exhibit 10.39 to the Registrant’s Annual Report on Form 10-K filed on March 27, 2025.)
Amended and Restated Executive Employment Agreement, dated March 13, 2025, between Savara Inc.
and Kathleen McCabe.
−Removed: Master Services Agreement by and between Savara ApS and Selvita S.A., effective January 17, 2024.
+Added: (Incorporated by reference to Exhibit 10.40 to the Registrant’s Annual Report on Form 10-K filed on March 27, 2025.)
+Added: 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.)
+Added: 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.
+Added: (Incorporated by reference to Exhibit 10.1 of the Registrant's Quarterly Report on Form 10-Q filed on May 13, 2025.)
+Added: Purchase and Sales Agreement By and Between Savara Inc.
+Added: 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.
+Added: Executive Employment Agreement, dated December 9, 2025, between Savara Inc.
+Added: and Yasmine Wasfi.
+Added: 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.
+Added: 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).
+Added: Insider Trading and Disclosure Policy.
+Added: (Incorporated by reference to Exhibit 19.1 to the Registrant’s Annual Report on Form 10-K/A filed on April 25, 2025.)
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.
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Indicates management contract or compensatory plan
−Removed: Indicates confidential treatment has been granted to certain portions of this exhibit, which portions have been omitted and filed separately with the SEC.
+Added: Certain portions of this exhibit have been redacted pursuant to Item 601(b)(10) of Regulation S-K.
+Added: Filed herewith.
These certifications are being furnished solely to accompany this report pursuant to 18 U.S.C.
58 unchanged sentences
Critical Audit Matter
−Removed: The critical audit matter communicated below is a matter arising from the current period audit of the financial statements that was communicated or required to be communicated to the audit committee and that:
−Removed: (1) relates to accounts or disclosures that are material to the financial statements and (2) involved our especially challenging, subjective or complex judgments.
−Removed: The communication of the critical audit matter does not alter in any way our opinion on the financial statements, taken as a whole, and we are not, by communicating the critical audit matter below, providing separate an opinion on the critical audit matter or on the accounts or disclosures to which it relates.
−Removed: As described in Note 2 to the financial statements, the Company records expenses of research and development activities, including nonclinical studies, and third-party contract services for clinical trials and manufacturing development.
+Added: 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:
+Added: (1) relates to accounts or disclosures that are material to the consolidated financial statements and (2) involved our especially challenging, subjective or complex judgments.
+Added: 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.
+Added: Research and Development Costs
+Added: 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.
−Removed: Though expenses are based on signed agreements, the complexity involved in determining expenses arises from agreements containing multiple milestones that require management’s careful analysis with external parties to determine period expenses and potential contractual milestone expenses based on the progress made against benchmarks including but not limited to patients enrolled, services performed, and equipment purchased.
+Added: 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.
59 unchanged sentences
Tax credit income
+Added: Loss on extinguishment of debt
Total other income, net
5 unchanged sentences
Gain (loss) on foreign currency translation
−Removed: Unrealized gain on short-term investments
+Added: Unrealized gain (loss) on short-term investments
Total comprehensive loss
8 unchanged sentences
Balance on December 31, 2023
−Removed: Issuance of common stock and pre-funded warrants in
−Removed: underwritten public offering, net of offering cost
+Added: Issuance of common stock in underwritten public
+Added: offering, net of offering cost
+Added: Issuance of common stock upon at the market
+Added: offerings, net
Issuance of common stock upon exercise
2 unchanged sentences
Repurchase of shares for minimum tax withholdings
−Removed: Issuance of common stock upon at the market
−Removed: offerings, net
+Added: Issuance of common stock upon exercise of prefunded
+Added: Reimbursement of commissions from prior issuance of
+Added: common stock upon at the market sales, net
Stock-based compensation
2 unchanged sentences
Balance on December 31, 2024
−Removed: Issuance of common stock in underwritten public offering,
−Removed: net of offering cost
−Removed: Issuance of common stock upon at the market
−Removed: offerings, net
+Added: Issuance of common stock and pre-funded warrants in
+Added: underwritten public offering, net of offering cost
+Added: Issuance of common stock upon exercise of pre-funded
Issuance of common stock upon exercise
2 unchanged sentences
Repurchase of shares for minimum tax withholdings
−Removed: Issuance of common stock upon exercise of prefunded
−Removed: Reimbursement of commissions from prior issuance of
−Removed: common stock upon at the market sales, net
Stock-based compensation
11 unchanged sentences
Reduction in the carrying value of right-of-use assets
−Removed: Foreign currency loss
Amortization of debt issuance costs
+Added: Loss on extinguishment of debt
Accretion on discount to short-term investments
9 unchanged sentences
Maturity of available-for-sale securities
+Added: Sale of available-for-sale securities, net
Net cash used in investing activities
Cash flows from financing activities:
−Removed: Issuance of common stock and pre-funded warrants in underwritten offering, net of offering costs
+Added: Repayment of long-term debt
+Added: Proceeds from long-term debt, net
Issuance of common stock issued in underwritten offering, net of offering costs
7 unchanged sentences
Effect of exchange rate changes on cash and cash equivalents
−Removed: Decrease in cash and cash equivalents
+Added: Increase (decrease) in cash and cash equivalents
Cash and cash equivalents beginning of period
8 unchanged sentences
(together with its subsidiaries “Savara,” the “Company,” “we” or “us”) is a clinical-stage biopharmaceutical company focused on rare respiratory diseases.
−Removed: The Company’s sole program, molgramostim inhalation solution ( " MOLBREEVI" or "molgramostim") , is an investigational inhaled biologic, specifically an inhaled granulocyte-macrophage colony-stimulating factor ("GM-CSF") in Phase 3 development for autoimmune pulmonary alveolar proteinosis (“aPAP”).
+Added: 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.
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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.
−Removed: The Company is currently focused on the development of MOLBREEVI for the treatment of aPAP and believes such activities will result in the continued incurrence of significant research and development and other expenses related to this program.
+Added: 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.
3 unchanged sentences
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.
−Removed: The Company may continue to raise additional capital as needed through the issuance of additional equity securities and potentially through borrowings and strategic alliances with partner companies.
+Added: 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.
−Removed: The Company currently maintains depository accounts and has a debt facility with Silicon Valley Bank, an FDIC insured entity.
+Added: 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.
23 unchanged sentences
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.
−Removed: Unrealized losses are evaluated for impairment under ASC 326, Financial Instruments - Credit Losses, to determine if the impairment is credit-related or noncredit-related.
+Added: 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.
13 unchanged sentences
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.
−Removed: Accruals are recorded based on
−Removed: estimates of services received and efforts expended pursuant to agreements established with CROs, CMOs, and other outside service providers.
+Added: 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.
16 unchanged sentences
Acquired In-Process Research and Development
−Removed: In accordance with ASC Topic 350, Intangibles – Goodwill and Other , the Company's acquired IPR&D is determined to have an indefinite life and, therefore, is not amortized.
+Added: 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.
−Removed: With respect to the impairment testing of acquired IPR&D, ASU 2011-08, Intangibles – Goodwill and Other (Topic 350):
+Added: 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):
42 unchanged sentences
The Company’s financial instruments consist primarily of cash, cash equivalents, short term investments, accounts payable, and accrued liabilities.
−Removed: The Company’s cash, cash equivalents, accounts payable, and accrued liabilities
−Removed: approximate fair value due to their relatively short maturities.
+Added: The Company’s cash, cash equivalents, accounts payable, and accrued liabilities approximate fair value due to their relatively short maturities.
Refer to Note 8.
24 unchanged sentences
Income Taxes for additional discussion.
−Removed: Recent Accounting Pronouncements
−Removed: In November 2023, the FASB issued Accounting Standards Update ("ASU") 2023-07, Segment Reporting (Topic 280):
−Removed: Improvements to Reportable Segment Disclosures (" ASU 2023-07"), to provide more disaggregated expense information about a public entity’s reportable segments.
−Removed: The amendments in this update should be applied retrospectively and are effective for fiscal years beginning after December 15, 2023, and interim periods beginning after December 15, 2024.
−Removed: As of January 1, 2024 , we have adopted ASU 2023-07 which did no t have a material impact on the Company's consolidated financial statements and additional required disclosures have been included in Note 13.
−Removed: Segment Reporting.
−Removed: In December 2023, the FASB issued ASU 2023-09, Income Taxes (Topic 740):
−Removed: Improvements to Income Tax Disclosures ("ASU 2023-09"), to require disaggregated information about a reporting entity’s effective tax rate reconciliation as well as information on income taxes paid.
−Removed: The amendments in this update should be applied prospectively, with an option to apply them retrospectively, and are effective for fiscal years beginning after December 15, 2024 for public entities.
−Removed: 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.
+Added: Recently Adopted Accounting Pronouncements
+Added: 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.
+Added: ASU 2023-09 requires greater disaggregation of income tax disclosures related to the income tax rate reconciliation and income taxes paid.
+Added: The Company adopted this new standard for the year ended December 31, 2025 .
+Added: These amendments have been applied on a prospective basis in the financial statements.
+Added: The required disclosure enhancements of ASU 2023-09 did not have a material impact on the Company's consolidated financial statements.
+Added: Income Taxes for further details.
+Added: 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):
8 unchanged sentences
Prepaid insurance
+Added: Royalty purchase and sale agreement derivative
Deposits and other
1 unchanged sentence
Prepaid Contracted Research and Development Costs
−Removed: As of December 31, 2024, Prepaid contracted research and development costs are primarily comprised of contractual prepayments associated with the Company's clinical trial for MOLBREEVI for the treatment of aPAP and for CMC related activities.
+Added: 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.
9 unchanged sentences
Accrued general and administrative costs
+Added: Royalty agreement derivative liability
Lease liability
4 unchanged sentences
Accrued Contracted Research and Development Costs
−Removed: As of December 31, 2024, Accrued contracted research and development costs are primarily comprised of costs associated with MOLBREEVI for the treatment of aPAP, including expenses resulting from obligations under agreements with CROs, CMOs, and other outside service providers that provide services in connection with the Company's research and development activities.
+Added: 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.
Short-term Investments
31 unchanged sentences
Debt Facility
−Removed: On April 21, 2022 , the Company and its subsidiary, Aravas Inc.
−Removed: (“Aravas”) entered into an Amended and Restated Loan and Security Agreement (the “Amended Loan Agreement”), as co-borrowers with Silicon Valley Bank, a division of First Citizens BancShares, as lender (the “Lender”) which provides for a $ 26.5 million term loan facility.
−Removed: Pursuant to the Amended Loan Agreement, the loan has an interest-only monthly payment through April 21, 2026 (the “Interest-Only Period”) and thereafter equal monthly installments of principal plus interest over 12 months until April 21, 2027 (the “Maturity Date”).
−Removed: However, the Company may elect to extend the Interest-Only Period until the Maturity Date if it maintains cash and cash equivalents equal to at least 1.75 times the outstanding principal amount of the loan during the fifth year.
−Removed: If the Interest-Only Period is extended, all principal and unpaid interest is due and payable on the Maturity Date.
−Removed: The loan bears interest at a floating rate equal to the greater of (i) 3 % and (ii) the prime rate reported in The Wall Street Journal, minus a spread of 0.5 %.
−Removed: The Company is obligated to pay customary closing fees and a final payment of 2.75 % of the principal amount advanced under the facility.
−Removed: The Company may currently prepay the loan in whole or in part at any time without penalty or prepayment fee.
−Removed: The Lender was granted a perfected first priority lien in all of the Company's assets with a negative pledge on intellectual property.
−Removed: The Amended Loan Agreement contains customary affirmative and negative covenants, including among others, covenants that limit the Company's and its subsidiaries’ ability to dispose of assets, permit a change in control, merge or
−Removed: consolidate, make acquisitions, incur indebtedness, grant liens, make investments, make certain restricted payments, and enter into transactions with affiliates, in each case subject to certain exceptions.
−Removed: Additionally, the Amended Loan Agreement contains an affirmative covenant providing that if the Company’s balance of cash and cash equivalents falls below $ 40.0 million, the Company is required to maintain cash and cash equivalents equal to at least (i) six months of operating expenses and (ii) 1.2 times the outstanding principal amount of the loan (or 1.75 in the final year of the loan if the Interest-Only Period is extended).
−Removed: The Company was obligated to issue warrants to purchase shares of its common stock as part of the initial funding of the loan, as further described in Note 9.
−Removed: Stockholders’ Equity .
−Removed: Approximately $ 0.1 million of fees paid to the Lender were capitalized and will be amortized over the term of the Amended Loan Agreement.
−Removed: Expenses paid to third parties associated with the Amended Loan Agreement were immediately expensed and recorded in the Interest income (expense) line item in our consolidated statement of operations.
+Added: 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.
+Added: 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.
+Added: 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.
+Added: The Hercules Loan Agreement provides t he Company may make further draws in the following tranches:
+Added: (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;
+Added: (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;
+Added: and (iii) subject to approval by the Lenders’ investment committees, up to $ 70 million.
+Added: The Term Loan will mature April 1, 2030 (the “Maturity Date”).
+Added: 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.
+Added: 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.
+Added: If the Company achieves the Approval Milestone, the Interest-Only period will extend until the Maturity Date.
+Added: 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.
+Added: 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.
+Added: 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").
+Added: 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).
+Added: 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.
+Added: Notwithstanding the foregoing, the Cash Requirement will not apply during any period when the Company’s market capitalization exceeds $ 600 million.
+Added: 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”).
+Added: 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.
+Added: 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.
+Added: 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.
+Added: 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.
+Added: The Company has identified certain embedded features within the Hercules Loan Agreement.
+Added: 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.
+Added: As of December 31, 2025, the Default Penalty does not have a discernable fair value and no amounts are recorded.
+Added: 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.
+Added: 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.
+Added: As amended, the Loan Agreement provides for the Company to borrow up to an aggregate of $ 105 million of term loans.
+Added: 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.
+Added: 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:
+Added: • 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”).
+Added: • 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.
+Added: Refer to Note 16.
+Added: 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
3 unchanged sentences
Unamortized end of term charge
−Removed: Debt issuance costs
−Removed: Debt discount related to warrants
Current portion of long-term debt
3 unchanged sentences
Assets and Liabilities Measured at Fair Value on a Recurring Basis
+Added: 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.
+Added: 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:
+Added: • Level 1—Inputs are unadjusted, quoted prices in active markets for identical assets or liabilities at the measurement date.
+Added: • 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
+Added: • Level 3—Inputs reflect management’s best estimate of what market participants would use in pricing the asset or liability at the measurement date.
+Added: Consideration is given to the risk inherent in the valuation technique and the risk inherent in the inputs to the model.
+Added: 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.
+Added: 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.
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government securities
+Added: Current liabilities:
+Added: Royalty purchase and sale agreement derivative
As of December 31, 2024
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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.
+Added: Royalty Purchase and Sale Agreement Derivative Liability
+Added: The derivative liability arose from the royalty purchase and sale agreement entered on October 29, 2025, as further described in Note 10.
+Added: 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.
+Added: 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.
+Added: This obligation would be settled in cash.
+Added: 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.
+Added: 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.
+Added: 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.
+Added: 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.
+Added: 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
3 unchanged sentences
As of December 31, 2025 and 2024, the Company had IPR&D of approximately $ 11.6 million and $ 10.3 million, respectively.
−Removed: For the years ended December 31, 2024 and 2023, the Company experienced a decrease of approximately $ 0.6 million and an increase of approximately $ 0.3 million, respectively, in the carrying value of IPR&D, which was due to foreign currency translation.
+Added: 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.
Stockh olders’ Equity
Underwritten Offering of Common Stock
+Added: 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”).
+Added: 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.
+Added: 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 .
+Added: 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):
+Added: Financial instruments
+Added: 2025 Pre-funded warrants
+Added: Estimated offering expenses
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.
4 unchanged sentences
Offering expenses
−Removed: On July 17, 2023, the Company sold (i) an aggregate of 21,000,000 shares of the Company’s common stock for $ 3.00 per share which represented a 1 % premium over the closing price on that date and (ii) pre-funded warrants to purchase an aggregate of 5,666,667 shares of the Company's common stock at an exercise price of $ 0.001 per share (the “2023 Pre-Funded Warrants”) for $ 2.999 per warrant pursuant to an underwritten offering (the “July 2023 Offering”).
−Removed: The Company determined that the securities issued in the July 2023 Offering were free-standing and that the 2023 Pre-Funded Warrants meet the equity classification requirements pursuant to ASC 480, Distinguishing Liability from Equity , ASC 815, Derivatives and Hedging and Subtopic 815-40, Accounting for Convertible Instruments and Contracts in an Entity’s Own Equity .
−Removed: The 2023 Pre-Funded Warrants were sold at the same price as the underlying common stock, less $ 0.001 (which represents the exercise price of the warrants).
−Removed: The July 2023 Offering resulted in net proceeds to the Company of approximately $ 74.9 million, after deducting final underwriting discounts, commissions, and other estimated offering expenses, as follows (in thousands):
−Removed: Financial instruments
−Removed: 2023 Pre-funded warrants
−Removed: Offering expenses
−Removed: Evercore Common Stock Sales Agreement
−Removed: On July 6, 2021, the Company entered into a Common Stock Sales Agreement with Evercore Group L.L.C.
−Removed: (“Evercore”), as sales agent (the “Sales Agreement”), pursuant to which the Company may offer and sell, from time to time, through Evercore, shares of Savara’s common stock, par value $ 0.001 per share (the “Shares”), having an aggregate offering price of not more than $ 100.0 million.
−Removed: The Sales Agreement was effective on July 16, 2021 , the date the Company’s Registration Statement on Form S-3 (File No.
−Removed: 333-257709) (the “2021 Registration Statement”), filed with the SEC on July 6, 2021, was declared effective by the SEC.
−Removed: From July 16, 2021 through May 20, 2024, Shares were sold pursuant to the 2021 Registration Statement.
−Removed: Since May 21, 2024, the Shares have been offered and sold pursuant to the 2024 Registration Statement.
−Removed: Subject to the terms and conditions of the Sales Agreement, Evercore will use commercially reasonable efforts to sell the Shares from time to time, based upon the Company’s instructions.
−Removed: The Company has provided Evercore with customary indemnification rights, and Evercore will be entitled to a commission at a fixed commission rate equal to 3 % of the gross proceeds per Share sold.
−Removed: Sales of the Shares, if any, under the Sales Agreement may be made in transactions that are deemed to be “at the market offerings” as defined in Rule 415 under the Securities Act of 1933, as amended.
−Removed: The Company has no obligation to sell any of the Shares and may at any time suspend sales under the Sales Agreement or terminate the Sales Agreement.
−Removed: During the year ended December 31, 2024 and 2023 , the Company sold 6,038,650 shares of the Company’s common stock resulting in net proceeds of $ 24.4 million and 2,071,511 shares of common stock resulting in net proceeds of $ 8.8 million to a single institutional investor pursuant to the Sales Agreement, respectively.
+Added: Evercore Common Stock Sales Agreement Termination
+Added: On July 6, 2021, the Company entered into a Sales Agreement with Evercore Group L.L.C.
+Added: (“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.
+Added: 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.
+Added: The Company is not subject to any termination penalties related to the termination of the ATM Agreement.
+Added: 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.
+Added: The Company did not sell any shares of common stock under the Sales Agreement d uring the year ended December 31, 2025.
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.
6 unchanged sentences
December 2018 Warrants
−Removed: 2017 Pre-funded Warrants
Pre-funded PIPE Warrants
1 unchanged sentence
2023 Pre-funded Warrants
+Added: 2025 Pre-funded Warrants
Stock options outstanding
18 unchanged sentences
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 .
−Removed: The Lease Amendment commenced on July 1, 2023 , continues through June 30, 2026 , or an additional thirty-six months , expands the existing office space, and increases the average monthly rent to approximately $ 14.5 thousand, paid over monthly installments during the Lease Amendment term.
−Removed: As of December 31, 2024, the carrying value of the right-of-use assets for the operating lease was $ 0.2 million, which is reflected in Other non-current assets and the carrying value of the lease liabilities for the operating lease increased to $ 0.3 million, of which approximately $ 0.2 million related to the current portion of the lease liabilities is recorded in Accrued expenses and other current liabilities and approximately $ 0.1 million related to the non-current portion of the lease liabilities is recorded in Other long-term liabilities .
+Added: The Lease Amendment commenced on July 1, 2023 , continues through June 30, 2026 , or an additional thirty-six
+Added: 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.
+Added: 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):
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Manufacturing and Other Commitments and Contingencies
−Removed: The Company is subject to various royalties and manufacturing and development payments related to its product candidate, MOLBREEVI .
−Removed: Under a manufacture and supply agreement with an active pharmaceutical ingredients (“API”) manufacturer for MOLBREEVI , as amended, the Company must make certain payments to the API manufacturer upon achievement of the milestones outlined in the table set forth below.
−Removed: Additionally, upon first receipt of marketing approval by the Company from a regulatory authority in a country for a product containing the API for therapeutic use in humans and ending the earlier of (i) ten (10) years thereafter or (ii) the date a biosimilar of such product is first sold in such country, the Company shall pay the API manufacturer a royalty equal to low-single digits of the net sales in that country of products containing API supplied by the API manufacturer.
−Removed: Additionally, the Company is subject to a purchase requirement under which for ten years following the date of receipt of approval by a regulatory authority of the first regulatory filing for the marketing and sale of the first product containing the API in any country, the Company will purchase from the API manufacturer the API required to produce a percentage of such product it sells each year (the “Purchase Requirement”);
−Removed: provided, however, that the Purchase Requirement will no longer apply if (i) the price charged by the API manufacturer exceeds a certain price charged by an alternative supplier, (ii) there is a shortage of supply, or (iii) API manufacturer at any time fails to materially fulfill a purchase order of the Company.
−Removed: The Company is also subject to certain contingent milestone payments, disclosed in the following table, payable to the manufacturer of the nebulizer used to administer MOLBREEVI .
−Removed: In addition to these milestones, the Company will owe a royalty of three-and one-half percent ( 3.5 %) to the manufacturer of the nebulizer based on net sales.
+Added: The Company has entered into a number of contracts for the manufacture of its product candidate, MOLBREEVI.
+Added: Some of these, as enumerated below entail various royalties and manufacturing and development payments.
+Added: FujiFilm Diosynth (“Fuji”)
+Added: 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.
+Added: 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 .
+Added: 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.
+Added: GEMABIOTECH SAU (“GEMA”)
+Added: 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.
+Added: 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.
+Added: 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”);
+Added: 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.
+Added: PARI Pharma GmbH (“PARI”)
+Added: 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.
+Added: In addition to these milestones, the Company will owe PARI a royalty of three-and one-half percent ( 3.5 %) based on net sales.
+Added: Milestone Payments
The following table summarizes manufacturing commitments and contingencies as of the period indicated (in thousands):
−Removed: Manufacturing, Development, and Other Contingent Milestone Payments (in thousands):
December 31, 2025
8 unchanged sentences
and (iii) not accrued, as the activities are not deemed probable or reasonably estimable, as of December 31, 2025 .
−Removed: Further, in February 2024, the Company entered into a master services agreement with an additional manufacturer to provide development and manufacturing services related to API for the Company’s MOLBREEVI product candidate in accordance with the terms of separate scope of work agreements and to perform a manufacturing campaign for process performance qualification of the API of MOLBREEVI.
−Removed: Under that master services agreement, work orders and subsequent change orders, the Company is currently obligated to pay the second source manufacturer, in total, estimated fees of $ 24.7 million of which $ 15.9 million has been recognized as expense during the year ended December 31, 2024.
−Removed: No expense was recognized in relation to this master services agreement during the year ended December 31, 2023.
−Removed: These costs are subject to various cancellation fees ranging from ten percent ( 10 %) to one hundred percent ( 100 %) of the cost of the respective activity based upon the timing of the commencement date and status of the activity.
Contract Research
−Removed: As part of its development of MOLBREEVI for the treatment of aPAP, the Company entered into a Master Services Agreement (“MSA”) with Parexel International (IRL) Limited (“Parexel”) pursuant to which Parexel will provide contract research services related to clinical trials.
−Removed: Contemporaneously with entering the MSA, a work order was executed with Parexel, under which they will provide services related to the IMPALA-2 trial.
−Removed: Under that work order and subsequent change orders, the Company is obligated to pay Parexel service fees, pass-through expenses, and investigator fees estimated to be approximately $ 48.5 million over the course of the IMPALA-2 clinical trial and trial close-out activities of which $ 9.2 million and $ 10.8 million has been recognized as expense during the years ended December 31, 2024 and 2023, respectively.
−Removed: In the second quarter of 2024, the Company initiated an open-label, multicenter clinical trial of MOLBREEVI in pediatric subjects with aPAP ("IMPACT") under a separate work order with Parexel.
−Removed: Pursuant to the IMPACT trial, Parexel currently
−Removed: has the opportunity to earn up to approximately $ 4.8 million in various milestone payments primarily dependent upon patient enrollment, site management, project oversight and the compliance with defined study protocols of which $ 1.3 million was recognized in the year ended December 31, 2024.
−Removed: No expense was recognized in relation to this work order during the year ended December 31, 2023.
+Added: 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.
+Added: 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.
+Added: 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.
+Added: 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.
+Added: 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.
+Added: Royalty Purchase and Sale Agreement
+Added: 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”).
+Added: 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.
+Added: 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.
+Added: 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”).
+Added: 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.
+Added: Unless otherwise agreed with the Purchaser, the Company is required to use a portion of the Purchase Price to repay all outstanding indebtedness.
+Added: 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.
+Added: 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.
+Added: 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.
+Added: 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.
+Added: 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.
+Added: 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
+Added: 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.
+Added: 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
1 unchanged sentence
Employment Agreements
−Removed: On December 8, 2020, the Company entered into an employment agreement with the Chief Executive Officer ("CEO"), as amended and restated on December 13, 2022, whereby the CEO is entitled to payments and benefits upon certain events.
+Added: 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.
2 unchanged sentences
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.
−Removed: Each of the Company’s Chief Financial & Administrative Officer (“CFO”), Chief Medical Officer (“CMO”), Chief Operating Officer ("COO"), Chief Business Officer ("CBO"), and Chief Commercial Officer ("CCO") is entitled to payments and benefits if the CFO, CMO, COO, CBO, or CCO, respectively, is (i) terminated without cause, (ii) terminated due to death or disability, or (iii) resigns for good reason, which includes (i) a lump sum payment equal to 12 months of base salary and a pro-rated portion of their unpaid bonus, (i i) reimbursement for continued coverage under medical benefit plans for 12 months or until covered under a separate plan from another employer, and (iii) accelerated vesting of outstanding non-vested Company equity awards equal to 12 months.
−Removed: Upon a termination other than for cause, death or disability or upon resignation for good reason within three months prior to or 12 months following a change in control, the CFO, CMO, COO, CBO, or CCO is entitled to receive (i) a lump sum payment of an amount equal to 18 months of base salary, plus 100% of their target bonus, plus a pro-rated portion of their unpaid target bonus, (ii) a lump sum payment equal to the amount required to continue coverage under medical benefit plans for 18 months, and (iii) the immediate and full vesting of outstanding non-vested options at the time of such termination.
+Added: 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.
+Added: 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.
+Added: On September 8, 2025, a putative securities class action complaint, Ho, et al.
+Added: Savara Inc., et al.
+Added: , was filed against the Company and certain of our executive officers in the United States District Court for the Eastern District of Pennsylvania.
+Added: 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.
+Added: The plaintiffs seek unspecified damages, costs and expenses, including attorneys’ fees.
+Added: 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.
+Added: Pauls, et al.
+Added: , respectively.
+Added: 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.
+Added: 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.
+Added: On February 6, 2026, the co-lead plaintiffs in the securities class action voluntarily dismissed the action without prejudice as to all defendants.
+Added: On February 12, 2026, the plaintiffs in the stockholder derivative action voluntarily dismissed the action without prejudice as to all defendants.
+Added: 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.
+Added: 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.
+Added: 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.
Stock -Based Compensation
−Removed: Equity Incentive Plans
The Company’s 2024 Omnibus Incentive Plan (the “2024 Plan”) was adopted by the Company’s board of directors in March 2024, was approved by the Company’s stockholders on June 6, 2024, and became effective on June 7, 2024.
1 unchanged sentence
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.
−Removed: The 2024 Plan provides for the grant of stock options (both incentive stock options and non-statutory stock options), stock appreciation rights, restricted stock, restricted stock units (“RSUs”), performance units, shares, and other stock-based awards.
+Added: 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.
1 unchanged sentence
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.
−Removed: The Inducement Plan provides for the grant of non-statutory stock options, restricted stock, RSUs, stock appreciation rights, performance units, and performance shares.
+Added: 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.
−Removed: Under the Inducement Plan and 2024 Plan, stock option grants typically vest quarterly over four years and expire ten years from the grant date and restricted stock unit grants typically cliff vest after two years .
The Savara Inc.
2 unchanged sentences
The outstanding awards granted under the 2008 Plan are fully vested and generally have a maximum contractual term of ten years .
−Removed: Stock Options and Restricted Stock Units
The Company values stock options using the Black-Scholes-Merton option pricing model, which requires the input of subjective assumptions, including the risk-free interest rate, expected life, expected stock price volatility, and dividend yield.
6 unchanged sentences
The valuation of stock options is also impacted by the valuation of common stock.
−Removed: Restricted stock units are valued at the closing market price of the Company’s common stock on the date of grant.
−Removed: Fair Value Assumptions for the Equity Incentive Plans
+Added: Restricted stock units, including PSUs, are valued at the closing market price of the Company’s common stock on the date of grant.
+Added: 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.
+Added: The 2025 PSUs are subject to certain performance conditions and a service condition.
+Added: 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.
+Added: The service condition is continuous employment or service with the Company through the date
+Added: the performance obligations may be achieved.
+Added: 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.
+Added: 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.
+Added: 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:
5 unchanged sentences
90.9 % - 114.6 %
−Removed: 91.2 % - 97.84 %
Dividend yield
14 unchanged sentences
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.
−Removed: Option Awards
Weighted-Average Grant Date Fair Value
1 unchanged sentence
Expired/cancelled/forfeited
+Added: Vested and deferred settlement
Outstanding at December 31, 2025
+Added: 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.
+Added: 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.
+Added: 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.
+Added: 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.
13 unchanged sentences
Total income tax expense
−Removed: A reconciliation of the expected income tax results computed using the federal statutory income tax rate to the Company’s effective income tax rate is as follows for the years ended December 31, 2024 and 2023 (in thousands):
+Added: As noted above, we adopted ASU 2023-09 on a prospective basis effective January 1, 2025.
+Added: The following table presents required disclosure pursuant to ASU 2023-09 and reconciles the U.S.
+Added: federal statutory tax amount and rate to our actual global effective amount and rate for the year ended December 31, 2025:
+Added: December 31, 2025
+Added: Income taxes, net of amounts refunded
+Added: Statutory tax rate difference between DK and US
+Added: Change in valuation allowance
+Added: Orphan drug tax credit
+Added: Change in valuation allowance
+Added: Nontaxable or Nondeductible Items
+Added: Imputed Interest Income
+Added: 162(m) Limitation
+Added: Other adjustments
+Added: (a) The company does not have any state income tax in current year.
+Added: 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):
+Added: December 31, 2024
Income tax benefit computed at federal statutory tax rate
19 unchanged sentences
ROU liabilities
+Added: Stock-based compensation
Accrued liabilities & other
10 unchanged sentences
Federal NOL carryforwards of $ 5.2 million begin to expire in 2037 , with $ 190.1 million not having an expiration date.
−Removed: As of December 31, 2024 and 2023 , the Company had state NOL
−Removed: carryforwards of approximately $ 25.0 million and $ 9.5 million, respectively.
+Added: 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.
2 unchanged sentences
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.
+Added: On July 4, 2025, H.R.
+Added: 1 – OBBBA, the One Big Beautiful Bill Act (“OBBBA”), was signed into law.
+Added: 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.
+Added: Given the Company’s history of net operating losses, OBBBA did not have a significant impact on the Company’s financial statements.
The Company applies the accounting guidance in ASC 740 Income Taxes related to accounting for uncertainty in income taxes.
8 unchanged sentences
There are currently no federal, state, or foreign income tax audits in progress.
+Added: New Accounting Pronouncement Adoption
+Added: 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:
+Added: December 31, 2025
+Added: Income taxes, net amounts refunded
Segment Reporting
2 unchanged sentences
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.
−Removed: The Company and its CODM do not distinguish between potential markets for the purpose of making decisions about resource allocation and performance assessment of its sole pre-revenue development program, MOLBREEVI, for the treatment of aPAP.
+Added: 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.
1 unchanged sentence
Therefore, no geographical segmen ts are presented.
−Removed: In addition to the significant expense categories included on the Company's consolidated statements of operations, refer below for disaggregated amounts that comprise research and development expenses and the segment net loss (in thousands):
+Added: In addition to the significant expense categories included on the Company's
+Added: 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,
13 unchanged sentences
(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.
−Removed: (b) Other segment income (expense), net includes interest income, interest expense, foreign currency exchange gain or loss, depreciation and amortization, non-cash stock-based compensation and tax credit income.
+Added: (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.
Net L oss per Share
16 unchanged sentences
The Company offers a defined contribution 401(k) plan for its employees.
−Removed: Employees are eligible to participate in the plan beginning on the first day following the three month anniversary date of hire.
+Added: 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.
−Removed: The Company makes discretionary contributions to the 401(k) plan equal to 100 percent of each employee’s pretax contributions up to the IRS annual contribution limit.
+Added: 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.
3 unchanged sentences
Loan Agreement
−Removed: On March 26, 2025 (the “Closing Date”), the Company, as borrower, entered into a Loan and Security Agreement (the “Hercules Loan Agreement”) with the lenders party thereto (the “Lenders”) and Hercules Capital, Inc., as administrative agent and collateral agent (the “Agent”).
−Removed: The Hercules Loan Agreement provides for the Company to borrow up to $200 million of term loans (the “Term Loan”).
−Removed: The initial advance of $30 million under the Hercules Loan Agreement was drawn on the Closing Date and used to repay all outstanding obligations under the Company’s prior term loan with Silicon Valley Bank, described in Footnote 7.
−Removed: Debt Facility , to pay the Company’s expenses in connection with the Hercules Loan Agreement, and for general corporate purposes.
−Removed: The Company may draw further Term Loans in the following tranches:
−Removed: (i) subject to FDA approval of the Company’s MOLBREEVI product candidate for the treatment of aPAP (the “Approval Milestone”), (a) up to $40 million on or prior to March 15, 2026 and (b) up to $40 million on or prior to December 15, 2026;
−Removed: (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;
−Removed: and (iii) subject to approval by the Lenders’ investment committees, up to $70 million.
−Removed: The Term Loan will mature April 1, 2030 (the “Maturity Date”).
−Removed: The Term Loan bears interest at a floating rate equal to (i) the greater of (a) the prime rate reported in The Wall Street Journal or (b) 6.0%, plus (ii) 1.45%, or, subject to the Company meeting the Revenue Milestone, 1.20% after the full fiscal quarter following such achievement.
−Removed: 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.
−Removed: If the Company achieves the Approval Milestone, the Interest-Only period will extend until the Maturity Date.
−Removed: 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.
−Removed: The Hercules Loan Agreement includes customary affirmative and negative covenants, repayment and prepayment terms, representations and warranties, and events of default.
−Removed: 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).
−Removed: 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.
−Removed: Notwithstanding the foregoing, the Cash Requirement will not apply during any period when the Company’s market capitalization exceeds $600 million.
−Removed: 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”).
−Removed: 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.
−Removed: 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.
+Added: On January 26, 2026, the Company entered into a First Amendment (the “First Amendment”) to the Hercules Loan Agreement as described in Note 7.
+Added: Debt Facility , with the Lenders.
+Added: As amended, the Hercules Loan Agreement provides for the Company to borrow up to an aggregate of $ 105 million of term loans.
+Added: 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”).
+Added: 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:
+Added: • 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”).
+Added: • 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.
+Added: 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.
+Added: 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.
+Added: Commitments prior to receiving funds under the Purchase Agreement and so long as the Company maintains $ 50 million or more in unrestricted cash.
+Added: 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.
+Added: Commitments to our consolidated financial statements in this Annual Report on Form 10-K, voluntarily dismissed the action without prejudice as to all defendants.
+Added: On February 12, 2026, the plaintiffs in the stockholder derivative action described in Note 10.
+Added: Commitments to our consolidated financial statements in this Annual Report on Form 10-K voluntarily dismissed the action without prejudice as to all defendants.
+Added: New Lease Agreement
+Added: On March 10, 2026 , the Company entered into a lease agreement (the “New PA Lease”) for its office headquarters in Yardley, Pennsylvania.
+Added: The New PA Lease shall commence on July 1, 2026 and continues through November 30, 2031 .
+Added: 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 .
Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.