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(together with its subsidiaries “Savara,” the “Company,” “we,” “our” or “us”) is a clinical-stage biopharmaceutical company focused on rare respiratory diseases.
−Removed: Our sole program, MOLBREEVI, is an inhaled biologic, specifically, inhaled granulocyte-macrophage colony-stimulating factor ("GM-CSF") in Phase 3 development for aPAP.
−Removed: Savara previously announced positive top-line results from the Phase 3 clinical trial and plans to complete a Biological License Application submission with the FDA in the first quarter of 2025.
+Added: Our sole program, MOLBREEVI, an inhaled biologic, is a granulocyte-macrophage colony-stimulating factor ("GM-CSF") in development for autoimmune pulmonary alveolar proteinosis ("autoimmune PAP").
+Added: Savara previously announced positive topline results from IMPALA-2, the Phase 3 clinical trial of MOLBREEVI in autoimmune PAP and the submission of the Biologics License Application ("BLA") to the FDA for MOLBREEVI in autoimmune PAP.
+Added: In May 2025, Savara announced the Company had received a Refusal to File letter ("RTF") from the FDA.
+Added: The Company resubmitted the BLA in December 2025 and requested Priority Review, and the FDA formally filed the BLA for MOLBREEVI in February 2026 and granted Priority Review.
+Added: MOLBREEVI in autoimmune PAP has been granted Fast Track and Breakthrough Therapy Designations by the FDA, Orphan Drug Designation by the FDA and the European Medicines Agency ("EMA"), as well as Innovation Passport ("IP") and Promising Innovative Medicine ("PIM") designations by the UK’s Medicines and Healthcare Products Regulatory Agency ("MHRA").
Savara, together with its wholly-owned subsidiaries, which include Aravas Inc.
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BLA Submission Complete
−Removed: On March 26, 2025, Savara announced that it had completed its submission of the BLA to the FDA for MOLBREEVI for the potential treatment of aPAP, a chronic and debilitating rare lung disease characterized by the abnormal build-up of surfactant in the alveoli of the lungs.
−Removed: This follows our reporting, in June 2024, of top line results from our pivotal IMPALA-2 trial for the treatment of aPAP that demonstrated significant improvement in gas exchange, or DLCO, and clinical benefit, as measured SGRQ.
−Removed: MOLBREEVI was also well tolerated throughout the 48-weeks and no unexpected safety signals were seen.
−Removed: Previously, on December 18, 2024, the Company announced that it had initiated a rolling submission of a BLA to the FDA for MOLBREEVI.
−Removed: MOLBREEVI was also granted Fast Track and Breakthrough Therapy Designations in 2019 for the treatment of patients with aPAP.
+Added: On December 22, 2025, Savara announced that it had resubmitted the MOLBREEVI BLA to the FDA for the potential treatment of autoimmune PAP, a chronic and debilitating rare lung disease characterized by the abnormal build-up of surfactant in the alveoli.
+Added: The Company requested Priority Review of the application.
+Added: In February 2026, the FDA formally filed the BLA for MOLBREEVI and granted Priority Review.
+Added: October 2025 Underwritten Public 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
+Added: Warrants”) for $4.199 per pre-funded warrant (collectively, the “October 2025 Offering”).
+Added: The October 2025 Offering was made pursuant to the Company’s shelf registration statement on Form S-3 (File No.
+Added: 333-279274), which was previously filed with the Securities Exchange Commission on May 9, 2024 and declared effective on May 21, 2024, and a prospectus supplement filed with the SEC on October 30, 2025.
+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.
+Added: The Company intends to use the net proceeds for working capital and general corporate purposes, which include, but are not limited to, the funding of clinical development of and pursuing regulatory approval for MOLBREEVI, investing in our commercialization infrastructure and supply, commercial launch preparation activities in the United States and European Union and general and administrative expenses.
+Added: Royalty Purchase and Sale Agreement
+Added: On October 29, 2025, we entered into the Purchase Agreement, pursuant to which the Purchaser agreed to pay us $75.0 million upon approval of MOLBREEVI by the FDA on or before March 31, 2027 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 United States.
Debt Financing
−Removed: On March 26, 2025, the Company announced that it had 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”) that may be advanced in multiple tranches.
−Removed: The initial advance of $30 million under the Hercules Loan Agreement was drawn on March 26, 2025 and used to repay all outstanding obligations under the Company’s Amended Loan Agreement with Silicon Valley Bank as described in Footnote 7.
−Removed: Debt Facility and extinguish the Company’s obligations thereunder, to pay the Company’s expenses in
−Removed: connection with the Hercules Loan Agreement, including fees and expenses relating to termination of the Silicon Valley Bank term loan, and for general corporate purposes.
−Removed: Further Term Loan draws may be made by the Company under the Hercules Loan Agreement as follows:
−Removed: • Subject to FDA approval of MOLBREEVI for the treatment of aPAP (the “Approval Milestone”), the Company may draw (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: • 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”), the Company may draw up to $20 million on or prior to December 31, 2027.
−Removed: • Subject to approval by the Lenders’ investment committees, the Company may draw up to $70 million of additional funds.
−Removed: Continued Funding of Federal Government Operations and Federal Debt Limit
−Removed: On December 20, 2024, the U.S.
−Removed: Congress advanced the American Relief Act, 2025 (H.R.
−Removed: 10545), a continuing resolution ("CR") that funds the federal government until March 14, 2025.
−Removed: On March 14, 2025, the 119th U.S.
−Removed: Congress, voted to pass an additional stopgap CR, as subsequently executed by President Trump, which continues the funding of the federal government through September 2025 and avoids interruptions to the operations of the government.
−Removed: Congress will also have to address the federal debt limit, as the Fiscal Responsibility Act ("FRA") suspended the debt limit on January 2, 2025.
−Removed: The outcome and impact of a potential future government shutdown and adequately addressing the federal debt limit to our operations is uncertain;
−Removed: however, we are actively assessing and monitoring the potential impacts and situation.
−Removed: Impact of Potential Tariffs
−Removed: Effective February 1, 2025, U.S.
−Removed: President Donald Trump announced the potential implementation of a 25% additional tariff on imports from Canada and Mexico and a 10% additional tariff on imports from China, while energy resources from Canada are subject to a lower 10% tariff.
−Removed: The tariffs since have been subject to delay, changes, and in some cases implemented.
−Removed: President Trump has similarly communicated the potential implementation of additional tariffs on additional imported goods and imported goods from other countries.
−Removed: Collectively, these tariffs could affect a substantial portion of available U.S.
−Removed: marketed medical devices and drug substances that are manufactured solely outside of the U.S.
−Removed: We continue to monitor and assess the potential impacts of potential tariffs on our operations and supply chain.
+Added: On January 26, 2026, we entered into the First Amendment to the Hercules Loan Agreement.
+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 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 First Amendment, upon achievement of the Approval Milestone, the Company may borrow up to $75 million of additional term loans under the 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: Refer to Note 7.
+Added: Debt Facility and Note 16.
+Added: Subsequent Events in the notes to our consolidated financial statements in this annual report on Form 10-K for additional discussion.
+Added: Litigation Dismissal
+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.
Critical Accounting Policies and Estimates
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We make significant judgments and estimates in determining the accrual balance in each reporting period.
−Removed: In the event advance payments are made to a CRO, CMO, or outside service provider,
−Removed: the payments will be recorded as a prepaid asset which will be amortized or expensed as the contracted services are performed.
+Added: In the event advance payments are made to a CRO, CMO, or outside service provider, the payments will be recorded as a prepaid asset which will be amortized or expensed as the contracted services are performed.
As actual costs become known, we adjust our prepaids and accruals and related expense.
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Research and development expenses increased $3.4 million, or 4.3%, to $81.4 million for the year ended December 31, 2025 from $78.0 million for the year ended December 31, 2024.
−Removed: This increase is primarily due to the performance of tasks related to our MOLBREEVI program which includes approximately $19.9 million of costs related to our chemistry, manufacturing, and controls activities, primarily driven by initiatives to establish our second drug substance manufacturer, $2.8 million of costs related to our IMPALA-2 trial, IMPACT trial, and Savara EAP, including CRO-related activities, $4.1 million of costs related to regulatory affairs and quality assurance, and $7.0 million due to an increase in personnel and related costs and other departmental overhead.
+Added: This increase is primarily due to the performance of tasks related to our MOLBREEVI program, which includes $5.7 million of costs related to regulatory affairs and quality assurance, primarily driven by the BLA submission;
+Added: $0.5 million of costs related to our chemistry, manufacturing, and controls activities;
+Added: $1.0 million other departmental overhead;
+Added: partially offset by a decrease of $3.8 million in clinical costs.
General and Administrative
General and administrative expenses increased $17.0 million, or 68.0%, to $42.1 million for the year ended December 31, 2025 from $25.0 million for the year ended December 31, 2024.
−Removed: The increase is due to personnel and related costs of $4.3 million, certain commercial activities of $3.8 million, and other overhead of $1.3 million primarily driven by patient advocacy activities and consultant costs.
+Added: The increase is due to higher personnel and related costs, in terms of compensation and an increase in valuation and stock awards, driven by strategic workforce expansion to support and scale operations of $11.2 million;
+Added: certain commercial activities of $3.1 million;
+Added: and other overhead of $2.7 million primarily driven by expanded patient advocacy and medical affairs activities.
Other Income, Net
−Removed: Other income, net increased $2.0 million to $7.3 million for the year ended December 31, 2024 from $5.3 million for the year ended December 31, 2023.
−Removed: The increase is primarily related to an increase in interest income as a result of higher
−Removed: balances and more favorable rates and returns on our short-term investments following various equity financings.
−Removed: Refer to Note 9.
−Removed: Stockholders’ Equity of the consolidated financial statements in this annual report on Form 10-K for additional discussion of the July 2024 Offering.
+Added: Other income, net decreased $2.6 million to $4.7 million for the year ended December 31, 2025 from $7.3 million for the year ended December 31, 2024.
+Added: The decrease is primarily related to lower interest income as a result of reduced balances and less favorable rates and returns on our short-term investments, in addition to a loss on extinguishment of debt.
Liquidity and Capital Resources
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As discussed in Note 7.
−Removed: Subsequent Events in the notes to the consolidated financial statements in this annual report on Form 10-K, on March 26, 2025, we entered into the Hercules Loan Agreement which provides for a loan facility of up to $200 million.
−Removed: Proceeds from the initial $30 million tranche drawn under the Hercules Loan Agreement were used to repay all outstanding obligations under the Amended Loan Agreement with Silicon Valley Bank, a division of First Citizens BancShares, with a carrying value of $26.6 million as described in Note 16.
−Removed: Subsequent Events , to pay certain expenses incurred in connection with the financing, and for general corporate purposes.
−Removed: Subject to satisfaction of certain conditions, including attainment of FDA approval of MOLBREEVI for the treatment of aPAP, we may draw future tranches under the Hercules Loan Agreement to fund our ongoing business operations including the development, regulatory approval, marketing and commercialization of MOLBREEVI.
+Added: Debt Facility and Note 16.
+Added: Subsequent Events in the notes to the consolidated financial statements in this annual report on Form 10-K, on March 26, 2025, we entered into the Hercules Loan Agreement which was amended by the First Amendment on January 26, 2026.
+Added: As amended, the Hercules Loan Agreement provides for the Company to borrow up to an aggregate of $105 million of term loans.
+Added: Proceeds from the initial $30 million tranche drawn under the Hercules Loan Agreement were used to repay all outstanding obligations under the Amended Loan Agreement with Silicon Valley Bank, a division of First Citizens BancShares, with a carrying value of $29.9 million, to pay certain expenses incurred in connection with the financing, and for general corporate purposes.
+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 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 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.
+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.
Common Stock Sales Agreement
−Removed: Evercore 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 Company’s Registration Statement on Form S-3 (File No.
−Removed: 333-279274), filed with the SEC on May 9, 2024 (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, we 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, in each case, to a single institutional investor pursuant to the Sales Agreement, respectively.
+Added: Effective April 2, 2025, the Company terminated the Sales Agreement, dated July 6, 2021, with Evercore Group, LLC (the “ATM Agreement”), pursuant to which the Company had been authorized to conduct "at the market offerings" (as defined as defined in Rule 415 under the Securities Act of 1933, as amended) of its common stock.
+Added: During the year ended December 31, 2024, the Company sold 6,038,650 shares of the Company’s common stock pursuant to the ATM Agreement resulting in net proceeds of $24.4 million.
+Added: The Company did not sell any shares of common stock under the ATM Agreement during the year ended December 31, 2025.
Recent Underwritten Offerings of Common Stock
+Added: We completed the October 2025 Offering, which resulted in net proceeds to the Company of approximately $140.2 million, after deducting final underwriting discounts, commissions, and other estimated offering expenses and including the
+Added: underwriter's option to purchase additional shares of our common stock at the public offering price as discussed in Note 9.
+Added: Stockholders’ Equity in the notes to the consolidated financial statements included in this annual report on Form 10-K.
On July 1, 2024, we sold an aggregate of 26,246,720 shares of our common stock, par value $0.001 per share, pursuant to an underwritten offering of our common stock (the "July 2024 Offering") at an offering price of $3.81 per share.
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Stockholders’ Equity in the notes to the consolidated financial statements included in this annual report on Form 10-K.
−Removed: On July 17, 2023, we completed an underwritten offering of our common stock and pre-funded warrants (the "July 2023 Offering") resulting in net proceeds of approximately $74.9 million as discussed in Note 9.
−Removed: Stockholders’ Equity in the notes to the consolidated financial statements included in this annual report on Form 10-K.
The following table summarizes our cash flows for the periods indicated:
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Cash used in operating activities for the year ended December 31, 2025 was $101.0 million, consisting of a net loss of $118.8 million offset by a net increase in operating assets and liabilities of $5.0 million and $12.8 million of net noncash charges.
+Added: The change in our net operating assets and liabilities was primarily due to an increase in accrued liabilities, specifically, compensation, research and development costs for MOLBREEVI, and the royalty agreement derivative.
+Added: Net noncash charges are comprised of depreciation and amortization including right-of-use assets, amortization of debt issuance costs, loss on extinguishment of debt, accretion on discount to short-term investments, and stock-based compensation.
+Added: Cash used in operating activities for the year ended December 31, 2024 was $89.1 million, consisting of a net loss of $95.9 million offset by a net increase in operating assets and liabilities of $1.8 million and $5.0 million of net noncash charges.
The change in our net operating assets and liabilities was primarily due to an increase in accrued liabilities, specifically, compensation and research and development costs for MOLBREEVI.
Net noncash charges are mainly comprised of amortization of debt issuance costs, accretion on discount to short-term investments, and stock-based compensation.
−Removed: Cash used in operating activities for the year ended December 31, 2023 was $51.1 million, consisting of a net loss of $54.7 million and a net increase in operating assets and liabilities of $4.1 million.
−Removed: The change in our net operating assets and liabilities was primarily due to an increase in accrued liabilities, specifically, compensation and research and development costs for MOLBREEVI.
−Removed: This was partially offset by approximately $0.5 million of non-cash charges, mainly comprised of amortization of debt issuance costs, accretion on discount/amortization on premium to short-term investments, and stock-based compensation.
Cash flows from investing activities
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Cash flows from financing activities
−Removed: Cash provided by financing activities of $117.6 million for the year ended December 31, 2024 was primarily the result of net proceeds from the July 2024 Offering and at the market offerings.
+Added: Cash provided by financing activities of $137.8 million for the year ended December 31, 2025 was primarily the result of net proceeds from the October 2025 Offering, net proceeds from the Hercules Loan Agreement partially offset by repayment of the SVB Loan, and repurchase of shares for minimum tax withholdings.
Refer to Note 9.
−Removed: Stockholders’ Equity of the consolidated financial statements in this annual report on Form 10-K for additional discussion of the July 2024 Offering.
+Added: Stockholders’ Equity of the consolidated financial statements in this annual report on Form 10-K for additional discussion of the October 2025 Offering.
Cash provided by financing activities of $117.6 million for the year ended December 31, 2024 was primarily the result of net proceeds from the July 2024 Offering and at the market offerings.
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The amount and timing of our future funding requirements will depend on many factors, including the pace and results of our clinical development efforts.
−Removed: Failure to raise capital as and when
−Removed: needed, on favorable terms or at all, would have a negative impact on our financial condition and our ability to develop our product candidate.
+Added: Failure to raise capital as and when needed, on favorable terms or at all, would have a negative impact on our financial condition and our ability to develop our product candidate.
Although we believe we are well capitalized based on our current operations, until we can generate a sufficient amount of product revenue to finance our cash requirements, we may finance our future cash needs primarily through the issuance of additional equity securities and potentially through borrowings, grants, and strategic alliances with partner companies.
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Refer to Note 2.
−Removed: Summary of Significant Accounting Policies – Recent Accounting Pronouncements , of the consolidated financial statements in this annual report on Form 10-K milestone for a discussion of recent accounting pronouncements and their effect, if any, on us.
+Added: Summary of Significant Accounting Policies – Recent Accounting Pronouncements , of the consolidated financial statements in this annual report on Form 10-K for a discussion of recent accounting pronouncements and their effect, if any, on us.
Quantitative and Qualitati ve Disclosures About Market Risk.
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Such interest earning instruments carry a degree of interest rate risk;
−Removed: however, we have not been exposed to, nor do we anticipate being exposed to, material risks due to changes in interest rates.
−Removed: A hypothetical 1% change in interest rates during any of the periods presented would not have had a material impact on our audited consolidated financial statements.
+Added: however, we have not been exposed, nor do we anticipate being exposed, to material risks due to changes in interest rates.
+Added: A hypothetical 1% change in interest rates during any of the periods presented would not have a material impact on our condensed consolidated financial statements.
Additionally, our investment securities are fixed income instruments denominated and payable in U.S.
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As such, we do not believe that our cash, cash equivalents, and short-term investment securities have significant risk of default or illiquidity.
−Removed: We have vendors in Denmark and elsewhere in Europe and pay those vendors in local currency, Danish Krone, British Pound sterling or Euros, respectively.
−Removed: We did not recognize any net exchange rate losses during the years ended December 31, 2024 and 2023.
−Removed: A 10% change in the Krone-to-dollar, British Pound sterling-to dollar exchange rate or Euro-to-dollar exchange rate on December 31, 2024 would not have had a material effect on our results of operations or financial condition.
−Removed: We also have interest rate exposure as a result of our Amended Loan Agreement with Silicon Valley Bank.
+Added: Interest Rate Risk
+Added: We also have interest rate exposure related to our long-term debt.
Refer to Note 7.
−Removed: Debt Facility of the consolidated financial statements in this annual report on Form 10-K for additional discussion.
−Removed: As of December 31, 2024, the carrying value of the secured term loan was $26.6 million.
−Removed: The loan bears interest at a floating rate equal to the greater of (i) 3% or (ii) the prime rate reported in The Wall Street Journal, which was 7.5% as of December 31, 2024, minus a spread of 0.5%.
−Removed: Changes in the prime rate may therefore affect our interest expense associated with our secured term loan.
−Removed: If a 10% change in interest rates from the interest rates on December 31, 2024 were to have occurred, this change would not have had a material effect on the value of our investment portfolio or on our interest expense obligations with respect to outstanding borrowed amounts.
−Removed: Additionally, inflation generally affects us by increasing our cost of labor and clinical trial costs.
+Added: Debt Facility and Note 16.
+Added: Subsequent Events in the notes to the consolidated financial statements in this annual report on Form 10-K.
+Added: The Hercules Loan Agreement bears interest equal to the greater of (i) the prime rate reported in The Wall Street Journal, plus 1.45%, which was 8.2% on December 31, 2025.
+Added: Changes in the prime rate would have impacted our interest expense associated
+Added: with our secured term loan.
+Added: If a 10% change in interest rates from the interest rates on December 31, 2025, were to have occurred, this change would not have had a material effect on our interest expense with respect to outstanding borrowed amounts.
+Added: Foreign Currency Exchange Risk
+Added: We use the U.S.
+Added: Dollar ("USD") as our functional and reporting currency, and therefore, are subject to the risk of fluctuations in foreign currency exchange rates.
+Added: The financial statements of the Company’s wholly-owned subsidiaries are recorded in their functional currency and translated into USD.
+Added: Our foreign currency exchange rate risk is primarily related to translation of our assets and liabilities from our foreign subsidiaries' functional currencies to USD.
+Added: The cumulative effect of changes in exchange rates between the foreign entity’s functional currency and the reporting currency is reported in Accumulated other comprehensive gain (loss) in the condensed consolidated balance sheet.
+Added: Additionally, we have vendors in Denmark, the United Kingdom, and elsewhere in Europe, and pay those vendors in local currency, Danish Krone, British Pound Sterling or Euros, respectively.
+Added: Accordingly, our results of operations and cash flows are subject to fluctuations due to changes in foreign currency exchange rates, particularly changes in the Euro, British Pound Sterling and Danish Krone.
+Added: Our expenses are generally denominated in the currencies of the jurisdictions in which we conduct our operations, which are primarily in the United States as well as the European Union and the United Kingdom.
+Added: Our results of operations and cash flows may be adversely affected due to an expansion of non-U.S.
+Added: dollar denominated contracts, growth of our international entities and operations and changes in foreign exchange rates or a weakening or strengthening of the USD against the Euro, British Pound Sterling and Danish Krone.
+Added: During the years ended December 31, 2025 and 2024, we recognized a gain on foreign currency translation of $0.7 million and a loss on foreign currency translation $0.5 million, respectively, recorded as a component of Other comprehensive income (loss) in our condensed statements of operations.
+Added: In general, the effect of a hypothetical 10% change in foreign currency exchange rates applicable to our business on December 31, 2025 would not have a material impact on our on our results of operations or financial condition.
+Added: We are currently not engaged in any hedging strategies.
+Added: As our international operations grow, we will continue to reassess our approach to manage the risk relating to fluctuations in currency rates.
+Added: Inflation Risk
+Added: Additionally, inflation generally affects us by increasing our cost of labor, supplies and clinical trial costs.
We do not believe that inflation has had a material effect on our results of operations during the periods presented.
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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.