Savara Inc

Previous wording

Savara Inc. (together with its subsidiaries “Savara,” the “Company,” “we,” “our” or “us”) is a clinical-stage biopharmaceutical company focused on rare respiratory diseases. 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"). Savara previously announced positive topline results from IMPALA-2, the Phase 3 clinical trial of MOLBREEVI for the treatment of autoimmune PAP and the submission of the Biologics License Application ("BLA") to the FDA for MOLBREEVI in autoimmune PAP. In February 2026, the FDA formally filed the BLA for MOLBREEVI and granted Priority Review. In March 2026, the European Medicines Agency (“EMA”) validated the submission of the MOLBREEVI marketing authorization application (“MAA”) in autoimmune PAP which will be reviewed by the Committee for Medicinal Products for Human Use. In April 2026, Savara announced that the U.K. Medicines and Healthcare Products Regulatory Agency (“MHRA”) validated the submission of the MOLBREEVI MAA for the treatment of autoimmune PAP in the U.K. subject to Accelerated Review with a 150-day assessment duration. In April 2026, Savara announced that the FDA extended the review period for the MOLBREEVI BLA to allow the FDA additional time to complete their review. The FDA determined that the Company’s responses to recent information requests by the Agency during their review constituted a major amendment to the BLA, resulting in a three-month extension of the Prescription Drug User Fee Act ("PDUFA") date to November 22, 2026. MOLBREEVI for the treatment of autoimmune PAP has been granted Fast Track and Breakthrough Therapy Designations by the FDA, Orphan Drug Designation by the FDA and the EMA, as well as Innovation Passport ("IP") and Promising Innovative Medicine ("PIM") designations by the MHRA. Savara, together with its wholly-owned subsidiaries, which include Aravas Inc. and Savara ApS, operate in one segment with its principal office in Langhorne, Pennsylvania, though a majority of our employees work remotely.

Current wording

Savara Inc. (together with its subsidiaries “Savara,” the “Company,” “we,” “our” or “us”) is a clinical-stage biopharmaceutical company focused on rare respiratory diseases. Our sole program, MOLBREEVI[1], an inhaled biologic, is a granulocyte-macrophage colony-stimulating factor (“GM-CSF”) in development for autoimmune pulmonary alveolar proteinosis ("autoimmune PAP"). Savara previously announced positive topline results from IMPALA-2, the Phase 3 clinical trial of MOLBREEVI for the treatment of autoimmune PAP and the submission of the Biologics License Application ("BLA") to the FDA for MOLBREEVI in autoimmune PAP. In February 2026, the FDA formally filed the BLA for MOLBREEVI and granted Priority Review. In March 2026, the European Medicines Agency (“EMA”) validated the submission of the MOLBREEVI marketing authorization application (“MAA”) in autoimmune PAP which will be reviewed by the Committee for Medicinal Products for Human Use. In April 2026, Savara announced that the U.K. Medicines and Healthcare Products Regulatory Agency (“MHRA”) validated the submission of the MOLBREEVI MAA for the treatment of autoimmune PAP in the U.K. subject to Accelerated Review with a 150-day assessment duration. In April 2026, Savara announced that the FDA extended the review period for the MOLBREEVI BLA to allow the FDA additional time to complete their review. The FDA determined that the Company’s responses to recent information requests by the Agency during their review constituted a major amendment to the BLA, resulting in a three-month extension of the Prescription Drug User Fee Act ("PDUFA") target action date to November 22, 2026. MOLBREEVI for the treatment of autoimmune PAP has been granted Fast Track and Breakthrough Therapy Designations by the FDA, Orphan Drug Designation by the FDA and the EMA, as well as Innovation Passport ("IP") and Promising Innovative Medicine ("PIM") designations by the MHRA. Savara, together with its wholly-owned subsidiaries, which include Aravas Inc. and Savara ApS, operate in one segment with its principal office in Yardley, Pennsylvania, though a majority of our employees work remotely.

Previous wording

We have never been profitable and have incurred operating losses every year since inception. Our net losses for the three months ended March 31, 2026 and 2025 were $37.3 million and $26.6 million, respectively. The net loss for the year ended December 31, 2025 was $118.8 million. As of March 31, 2026, we had an accumulated deficit of approximately $645.4 million. Our operating losses primarily resulted from expenses attributed to our research and development programs and from general and administrative costs associated with our operations.

Current wording

We have never been profitable and have incurred operating losses every year since inception. Our net losses for the three months ended June 30, 2026 and 2025 were $40.2 million and $30.4 million, respectively. The net loss for the year ended December 31, 2025 was $118.8 million. As of June 30, 2026, we had an accumulated deficit of approximately $685.6 million. Our operating losses primarily resulted from expenses attributed to our research and development programs and from general and administrative costs associated with our operations.

Previous wording

As of March 31, 2026, we had cash and cash equivalents of $38.8 million and short-term investments of $164.0 million. We will continue to require additional capital to continue our clinical development and potential commercialization activities. Although we have sufficient capital to fund many of our planned activities, we may need to continue to raise additional capital to further fund the development of, and seek regulatory approvals for, our product candidate and begin to commercialize any approved product. The amount and timing of our future funding requirements will depend on many factors, including the pace and results of our clinical development efforts and regulatory and commercial variability. 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.

Current wording

As of June 30, 2026, we had cash and cash equivalents of $41.8 million and short-term investments of $131.2 million. We will continue to require additional capital to continue our clinical development and potential commercialization activities. Although we have sufficient capital to fund many of our planned activities, we may need to continue to raise additional capital to further fund the development of, and seek regulatory approvals for, our product candidate and begin to commercialize any approved product. The amount and timing of our future funding requirements will depend on many factors, including the pace and results of our clinical development efforts and regulatory and commercial variability. 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.

Previous wording

General and administrative ("G&A") expenses consist primarily of consist of salaries, benefits and other related costs, including stock-based compensation, for our non-employee directors and personnel serving in our executive, finance and accounting, legal and compliance, commercial and pre-commercial, corporate development, field sales and human resource functions. G&A expenses also include professional fees for legal services, insurance, facility lease, investor relations, business development, board of director fees, consulting services, including information technology and tax and accounting services.

Current wording

General and administrative ("G&A") expenses consist primarily of salaries, benefits and other related costs, including stock-based compensation, for our non-employee directors and employees primarily serving in our executive, finance, legal, commercial and human resources functions. G&A expenses also include but are not limited to professional fees for legal services, insurance, facility lease, investor relations, business development, board of director fees, consulting services, including information technology and tax and accounting services.

Previous wording

Other income (expense) includes amortization expense related to capitalized debt issuance costs and debt discount under our loan agreements. Refer to Note 6. Debt Facility in the notes to the condensed consolidated financial statements included in this Quarterly Report. Interest expense is typically reported net of interest income which includes interest earned on our cash, cash equivalent, and short-term investment balances. Other income (expense) also includes net unrealized and realized gains and losses from foreign currency transactions, loss on extinguishment of debt, refundable tax credits generated by some of our foreign subsidiaries, and securities subject to fair value accounting as well as any other non-operating gains and losses.

Current wording

Other income (expense) includes amortization expense related to capitalized debt issuance costs and debt discount under our loan agreements. Refer to Note 6. Debt Facility in the notes to the condensed consolidated financial statements included in this Quarterly Report. Interest expense is typically reported net of interest income which includes interest earned on our cash, cash equivalents, and short-term investment balances. Other income (expense) also includes net unrealized and realized gains and losses from foreign currency transactions, loss on extinguishment of debt, refundable tax credits generated by some of our foreign subsidiaries, and securities subject to fair value accounting as well as any other non-operating gains and losses.

Previous wording

There have not been any material changes during the three months ended March 31, 2026, to the methodology applied by management for critical accounting policies previously disclosed in our Annual Report on Form 10-K for the year ended December 31, 2025. Please read Part II, Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations – Critical Accounting Policies and Estimates in our Annual Report on Form 10-K for the year ended December 31, 2025, for further description of our critical accounting policies.

Current wording

There have not been any material changes during the six months ended June 30, 2026, to the methodology applied by management for critical accounting policies previously disclosed in our Annual Report on Form 10-K for the year ended December 31, 2025. Please read Part II, Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations – Critical Accounting Policies and Estimates in our Annual Report on Form 10-K for the year ended December 31, 2025, for further description of our critical accounting policies.

Previous wording

Research and development expenses increased by $4.2 million, or 22.1%, to $23.4 million for the three months ended March 31, 2026 from $19.2 million for the three months ended March 31, 2025. This increase is primarily due to the performance of tasks related to our MOLBREEVI program, which includes approximately $2.5 million of costs related to our chemistry, manufacturing, and controls activities, primarily driven by activity at our drug substance manufacturer; $3.0 million of higher personnel costs, mainly related to increased share based compensation expense; partially offset by a decrease of $0.7 million of costs related to regulatory affairs consulting and quality assurance consulting and a decrease of $0.6 million of clinical costs.

Current wording

Research and development expenses increased by $1.2 million, or 5.8%, to $22.0 million for the three months ended June 30, 2026 from $20.8 million for the three months ended June 30, 2025. The increase was primarily due to $2.0 million of higher personnel costs, mainly related to increased stock-based compensation expense; partially offset by the performance of tasks related to our MOLBREEVI program, which includes a decrease of $0.2 million of costs related to our chemistry, manufacturing, and controls activities, primarily driven by activity at our drug substance manufacturer, and a decrease of $0.6 million of costs related to regulatory affairs consulting and quality assurance consulting costs.

Previous wording

There was no significant changes in Other income, net for the three months ended March 31, 2026 from the three months ended March 31, 2025.

Current wording

There were no significant changes in Other income, net for the three months ended June 30, 2026 from the three months ended June 30, 2025.

Previous wording

General and administrative expenses increased by $6.3 million, or 68.4%, to $15.6 million for the three months ended March 31, 2026 from $9.2 million for the three months ended March 31, 2025. The increase is primarily attributable to $6.0 million of higher personnel costs, mainly related to increased share based compensation expense; other departmental overhead of $0.6 million, partially offset by a decrease in certain commercial activities of $0.3 million.

Current wording

Research and development expenses increased by $5.4 million, or 13.6%, to $45.3 million for the six months ended June 30, 2026 from $39.9 million for the six months ended June 30, 2025. The increase was primarily due to $5.0 million of higher personnel costs, mainly related to increased stock-based compensation expense.

Previous wording

As of March 31, 2026, we had $38.8 million of cash and cash equivalents, $164.0 million in short-term investments, and an accumulated deficit of approximately $645.4 million. As discussed in Note 6. Debt Facility in the notes to the condensed consolidated financial statements included in this Quarterly Report, on March 26, 2025, we entered into the Hercules Loan Agreement, as amended, which provides for a loan facility of up to $105 million. Proceeds from the initial $30 million tranche drawn under the Hercules Loan Agreement, with a carrying value of $30.1 million, were used to repay all outstanding obligations under the SVB Loan, pay certain expenses incurred in connection with the financing, and for general corporate purposes. Subject to satisfaction of certain conditions, including attainment of FDA approval of MOLBREEVI for the treatment of autoimmune PAP, we may draw future tranches under the Hercules Loan Agreement and the royalty purchase and sale agreement with RTW Investments, LP, as discussed in Note 9. Commitments and Contingencies, to fund our ongoing business operations including the development, regulatory approval, marketing and commercialization of MOLBREEVI. Refer to Note 6. Debt Facility of the unaudited condensed consolidated financial statements in this quarterly report on Form 10-Q for additional discussion.

Current wording

As of June 30, 2026, we had $41.8 million of cash and cash equivalents, $131.2 million in short-term investments, and an accumulated deficit of approximately $685.6 million. As discussed in Note 6. Debt Facility in the notes to the condensed consolidated financial statements included in this Quarterly Report, on March 26, 2025, we entered into the Hercules Loan Agreement, which, as amended, provides for a loan facility of up to $105 million. Proceeds from the initial $30 million tranche drawn under the Hercules Loan Agreement, with a carrying value of $30.1 million, were used to repay all outstanding obligations under the SVB Loan, pay certain expenses incurred in connection with the financing, and for general corporate purposes. Subject to satisfaction of certain conditions, including attainment of FDA approval of MOLBREEVI for the treatment of autoimmune PAP, we may draw future tranches under the Hercules Loan Agreement, as amended, and the royalty purchase and sale agreement with RTW Investments, LP, as discussed in Note 9. Commitments and Contingencies, to fund our ongoing business operations including the development, regulatory approval, marketing and commercialization of MOLBREEVI. Refer to Note 6. Debt Facility of the unaudited condensed consolidated financial statements in this quarterly report on Form 10-Q for additional discussion.

Previous wording

Cash used in operating activities for the three months ended March 31, 2026 was $33.0 million, consisting of a net loss of $37.3 million and net $6.1 million in changes to operating assets and liabilities, offset by $10.4 million of net noncash charges. Net noncash charges are comprised primarily of stock-based compensation, accretion on discount to short-term investments, and amortization of debt issuance costs.

Current wording

Cash used in operating activities for the six months ended June 30, 2026 was $62.8 million, consisting of a net loss of $77.5 million and net $3.1 million in changes to operating assets and liabilities, offset by $17.8 million of net noncash charges. Net noncash charges are comprised primarily of stock-based compensation, accretion on discount to short-term investments, and amortization of debt issuance costs.

Previous wording

Cash provided by investing activities of $38.8 million for the three months ended March 31, 2026 was primarily associated with proceeds from maturities of short-term investments and sale of short-term investments.

Current wording

Cash provided by investing activities of $71.4 million for the six months ended June 30, 2026 was primarily associated with proceeds from maturities of short-term investments and purchases and sales of short-term investments.

Previous wording

As of March 31, 2026, we had cash, cash equivalents, and short-term investments of approximately $202.8 million. Although we have sufficient capital to fund our planned activities, including those discussed in Note 9. Commitments – Manufacturing and Other Commitments and Contingencies, in the notes to the condensed consolidated financial statements included in this Quarterly Report, we may need to raise additional capital to further fund the development of, and seek regulatory approvals for, our product candidate and to begin commercialization of any approved product.

Current wording

As of June 30, 2026, we had cash, cash equivalents, and short-term investments of approximately $173.0 million. Although we have sufficient capital to fund our planned activities, including those discussed in Note 9. Commitments – Manufacturing and Other Commitments and Contingencies, in the notes to the condensed consolidated financial statements included in this Quarterly Report, we may need to raise additional capital to further fund the development of, and seek regulatory approvals for, our product candidate and to begin commercialization of any approved product.

Previous wording

Except as set forth in Note 2. Summary of Significant Accounting Policies – Recent Accounting Pronouncements of the condensed consolidated financial statements in this Quarterly Report, there have been no material changes in our critical accounting policies and use of estimates during the three months ended March 31, 2026 as compared to those disclosed in “Part II, Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations—Critical Accounting Policies and Estimates” in the our Annual Report on Form 10-K for the year ended December 31, 2025.

Current wording

Except as set forth in Note 2. Summary of Significant Accounting Policies – Recent Accounting Pronouncements of the condensed consolidated financial statements in this Quarterly Report, there have been no material changes in our critical accounting policies and use of estimates during the six months ended June 30, 2026 as compared to those disclosed in “Part II, Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations—Critical Accounting Policies and Estimates” in our Annual Report on Form 10-K for the year ended December 31, 2025.