Savara Inc
For the period ended Sep 30, 2025. Filed Nov 12, 2025.
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A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.
Sep 30, 2025 · Filed Nov 12, 2025
SVRA$4.83+10.3%Stored close · as of Nov 6, 2026
What changed in Management’s Discussion and Analysis?
Read the current filingPrevious report: 10-Q
Period ended 2025-06-30; filed 2025-08-13.
0000950170-25-107631
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsCurrent report: 10-Q
Period ended 2025-09-30; filed 2025-11-12.
0001193125-25-277525
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsThe baseline is this issuer’s latest earlier reporting period of the same form that was filed before the current report. A previous 10-Q is a different quarter, not a year-over-year comparison. Amendments are excluded.
Compared 70 previous paragraphs and 74 current paragraphs.
44 unchanged; 20 reworded; 9 added; 5 removed; 1 previous and 1 current paragraphs rearranged.
Tables are not compared: 3 previous and 3 current tables excluded. Dates, whitespace, punctuation and numbering changes are ignored; changes to financial figures remain significant.
A changed paragraph is not evidence that risk increased or decreased. An unchanged paragraph does not establish that risk stayed the same.
Added paragraphs (9)
Current report
October 2025 Underwritten Public Offering of Common Stock
Current report
On October 31, 2025, the Company sold pursuant to an underwritten public offering (i) an aggregate of 28,452,381 shares of the Company’s common stock for $4.20 per share, including 4,642,857 shares of common stock sold pursuant to the exercise in full by the underwriters of their option to purchase additional shares, and (ii) pre-funded warrants to purchase an aggregate of 7,142,857 shares of common stock at an exercise price of $0.001 per share (the “2025 Pre-Funded Warrants”) for $4.199 per pre-funded warrant (collectively, the “October 2025 Offering”). The October 2025 Offering was made pursuant to the Company’s shelf registration statement on Form S-3 (File No. 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.
Current report
The October 2025 Offering resulted in net proceeds to the Company of approximately $140.0 million, after deducting final underwriting discounts, commissions, and other estimated offering expenses. 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.
Current report
Royalty Purchase and Sale Agreement
Current report
On October 29, 2025, we announced our entry into a purchase and sale agreement (the “Purchase Agreement”) with funds managed by RTW Investments, LP (the “Purchaser”). Under the terms of the Purchase Agreement, the Purchaser has agreed to pay us $75.0 million (the “Purchase Price”) 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 U.S. The royalty rate is tiered, with the payments ranging from 7.0% to 1.0% of Net Sales in each calendar year, with the 7.0% tier increasing to 9.5% for a calendar year if the prior year’s Net Sales do not achieve a specified level. The royalty payments commence in the first calendar quarter in which there is a commercial sale of MOLBREEVI in the United States and end upon the receipt by the Purchaser of $187.5 million (the “Maximum Payment”). The Purchase Agreement includes a buy-back option that may allow us to pay a specified amount up to the Maximum Payment to terminate the Purchase Agreement and all obligations in the event of certain changes of control within two years of receipt of the Purchase Price. Unless otherwise agreed with the Purchaser, we are required to use a portion of the Purchase Price to repay all outstanding indebtedness. The Purchase Agreement contains customary affirmative and negative covenants, including covenants that limit or restrict the Company’s ability to, among other things, incur indebtedness (which restrictions are eliminated after the achievement by the Company of a specified amount of Net Sales), and other provisions customary for transactions of this nature, in each case subject to certain exceptions set forth in the Purchase Agreement.
Current report
Government Shutdown
Current report
Effective October 1, 2025, the U.S. federal government shutdown due to the inability of the U.S. Congress to appropriate new funding for its 2026 budget, significantly impacting the FDA. While the FDA continues certain critical functions funded by user fees and public health exemptions, many non-essential activities have ceased or are experiencing delays. During this shutdown, the FDA is not accepting new drug applications, abbreviated new drug applications for generics, or BLA's. The review of pending drug applications that were submitted with user fees paid prior to the shutdown is expected to continue to the extent such proceeds are sufficient for the FDA to perform its regulatory operations; however, we cannot assure investors that the shutdown, if not lifted in the near term, will not impact the timing for acceptance or review of our BLA following our submission.
Current report
Other income, net decreased by $1.4 million to $0.7 million for the three months ended September 30, 2025 from $2.1 million for three months ended September 30, 2024. The decrease is primarily due to lower interest rates and lower investment balances.
Current report
In addition, we completed the October 2025 Offering resulted in net proceeds to the Company of approximately $140.0 million, after deducting final underwriting discounts, commissions, and other estimated offering expenses and including the underwriter's option to purchase additional shares of our common stock at the public offering price.
Removed paragraphs (5)
Previous report
Refusal To File Letter
Previous report
On May 27, 2025, Savara received an RTF letter from the FDA for the BLA of MOLBREEVI as a therapy to treat patients with autoimmune PAP. Upon preliminary review, the FDA determined that the BLA submitted in March 2025 was not sufficiently complete to permit substantive review and requested additional data related to Chemistry, Manufacturing, and Controls. The RTF was not the result of safety concerns, and the FDA did not request or recommend additional efficacy studies.
Previous report
Resubmission of BLA
Previous report
As a result of the RTF, Savara recently held a Type A meeting with the FDA. Following the meeting, the Company reached alignment with the Agency on information needed for resubmission the BLA with FujiFilm Diosynth as Savara’s drug substance manufacturer. Savara plans on resubmitting the BLA in December of 2025 and will request Priority Review.
Previous report
There was no significant changes in Other income, net for the three months ended June 30, 2025 and the three months ended June 30, 2024.
Reworded paragraphs (20)
Previous wording
This Quarterly Report on Form 10-Q (“Quarterly Report”) contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”). Any statements contained herein that involve risks and uncertainties, such as Savara’s plans, objectives, expectations, intentions, and beliefs should be considered forward-looking statements. Savara’s actual results could differ materially from those discussed in these forward-looking statements. Factors that could cause or contribute to such differences include, but are not limited to the following: the ability to project future cash utilization and reserves needed for contingent future liabilities and business operations, the risks associated with the process of conducting clinical trials and developing, obtaining regulatory approval for and commercializing drug candidates that are safe and effective for use as human therapeutics, the timing and ability to raise additional capital as needed to fund continued operations, natural disasters, pandemics, geopolitical events (including the war between Russia and Ukraine and the war in the Middle East), the Company’s ability to maintain compliance with its covenants under its long-term debt instruments and those discussed in the section entitled “Risk Factors” in this Quarterly Report and in our Annual Report on Form 10-K for the year ended December 31, 2024 filed with the Securities and Exchange Commission ("SEC") on March 27, 2025, all of which are difficult to predict.
Current wording
This Quarterly Report on Form 10-Q (“Quarterly Report”) contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”). Any statements contained herein that involve risks and uncertainties, such as Savara’s plans, objectives, expectations, intentions, and beliefs should be considered forward-looking statements. Savara’s actual results could differ materially from those discussed in these forward-looking statements. Factors that could cause or contribute to such differences include, but are not limited to the following: the ability to project future cash utilization and reserves needed for contingent future liabilities and business operations, the risks associated with the process of conducting clinical trials and developing, obtaining regulatory approval for and commercializing drug candidates that are safe and effective for use as human therapeutics, the timing and ability to raise additional capital as needed to fund continued operations, natural disasters, pandemics, geopolitical events (including the war between Russia and Ukraine and the war in the Middle East), the Company’s ability to maintain compliance with its covenants under its long-term debt instruments and those risks and uncertainties discussed in the section entitled “Risk Factors” in this Quarterly Report and in our Annual Report on Form 10-K for the year ended December 31, 2024 filed with the Securities and Exchange Commission ("SEC") on March 27, 2025, all of which are difficult to predict.
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 top-line 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. In May 2025, Savara announced the Company had received a Refusal to File ("RTF") letter from the FDA. The RTF was not the result of safety concerns, and the FDA did not request or recommend additional efficacy studies. The Company plans to resubmit the BLA in December 2025 and request Priority Review. 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, 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 top-line 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. In May 2025, Savara announced the Company had received a Refusal to File ("RTF") letter from the FDA. The RTF was not the result of safety concerns, and the FDA did not request or recommend additional efficacy studies. The RTF does not impact previous designations granted by regulators for MOLBREEVI in autoimmune PAP. 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). The Company plans to resubmit the BLA in December 2025 and request Priority Review. 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.
Previous 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, 2025 and 2024 were $30.4 million and $22.2 million, respectively, and our net losses for the six months ended June 30, 2025 and 2024 were $57.0 million and $42.6 million, respectively. The net loss for the year ended December 31, 2024 was $95.9 million. As of June 30, 2025, we had an accumulated deficit of approximately $546.3 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 September 30, 2025 and 2024 were $29.6 million and $24.2 million, respectively, and our net losses for the nine months ended September 30, 2025 and 2024 were $86.6 million and $66.8 million, respectively. The net loss for the year ended December 31, 2024 was $95.9 million. As of September 30, 2025, we had an accumulated deficit of approximately $575.9 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 June 30, 2025, we had cash and cash equivalents of $17.4 million and short-term investments of $129.0 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. 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 September 30, 2025, we had cash and cash equivalents of $16.3 million and short-term investments of $108.1 million. Additionally, on October 31, 2025 the Company completed a public offering of its common stock and certain pre-funded warrants which resulted in net proceeds to the Company of approximately $140.0 million, after deducting final underwriting discounts, commissions, and other estimated offering expenses and including the underwriter's option to purchase additional shares of our common stock at the public offering price. 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. 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
internal costs that are associated with activities performed by our research and development organization, consist primarily of:
Current wording
internal costs that are associated with activities performed by our research and development organization, consisting primarily of:
Previous wording
There have not been any material changes during the six months ended June 30, 2025, 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, 2024. 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, 2024, for further description of our critical accounting policies.
Current wording
There have not been any material changes during the nine months ended September 30, 2025, 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, 2024. 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, 2024, for further description of our critical accounting policies.
Previous wording
Research and development expenses increased by $3.1 million, or 17.8%, to $20.8 million for the three months ended June 30, 2025 from $17.6 million for the three months ended June 30, 2024. This increase is primarily due to the performance of tasks related to our MOLBREEVI program, which includes approximately $3.3 million of costs related to our chemistry, manufacturing, and controls activities, primarily driven by initiatives to establish our additional drug substance manufacturer, $1.1 million of costs related to regulatory affairs and quality assurance, partially offset by $1.3 million of clinical costs.
Current wording
Research and development expenses increased by $0.3 million, or 1.4%, to $20.6 million for the three months ended September 30, 2025 from $20.3 million for the three months ended September 30, 2024. This increase is primarily due to the performance of tasks related to our MOLBREEVI program, which includes approximately $0.3 million of costs related to our chemistry, manufacturing, and controls activities, primarily driven by initiatives to establish our additional drug substance manufacturer, $0.9 million of costs related to regulatory affairs and quality assurance and $0.6 million other departmental overhead, partially offset by a decrease of $1.5 million of clinical costs.
Previous wording
General and administrative expenses increased by $5.1 million, or 92.3%, to $10.7 million for the three months ended June 30, 2025 from $5.5 million for the three months ended June 30, 2024. The increase is primarily attributable to the strategic addition of personnel and related costs of $2.5 million, certain commercial activities of $1.5 million, and other departmental overhead of $1.1 million.
Current wording
General and administrative expenses increased by $3.6 million, or 60.1%, to $9.6 million for the three months ended September 30, 2025 from $6.0 million for the three months ended September 30, 2024. The increase is primarily attributable to the strategic addition of personnel and related costs of $2.9 million, certain commercial activities of $0.2 million, and other departmental overhead of $0.5 million.
Previous wording
Results of Operations – Comparison of Six Months Ended June 30, 2025 and 2024
Current wording
Results of Operations – Comparison of Nine Months Ended September 30, 2025 and 2024
Previous wording
Research and development expenses increased by $5.5 million, or 15.9%, to $39.9 million for the six months ended June 30, 2025 from $34.4 million for the six months ended June 30, 2024. This increase is primarily due to the performance of tasks related to our MOLBREEVI program, which includes approximately $3.8 million of costs related to our chemistry, manufacturing, and controls activities, primarily driven by initiatives to establish our additional drug substance manufacturer, $3.4 million of costs related to regulatory affairs and quality assurance, $0.1 million other departmental overhead, partially offset by $1.8 million of clinical costs.
Current wording
Research and development expenses increased by $5.8 million, or 10.5%, to $60.5 million for the nine months ended September 30, 2025 from $54.7 million for the nine months ended September 30, 2024. This increase is primarily due to the performance of tasks related to our MOLBREEVI program, which includes approximately $4.1 million of costs related to our chemistry, manufacturing, and controls activities, primarily driven by initiatives to establish our additional drug substance manufacturer, $4.3 million of costs related to regulatory affairs and quality assurance and $0.7 million other departmental overhead, partially offset by a decrease of $3.3 million of clinical costs.
Previous wording
General and administrative expenses increased by $8.7 million, or 78.1%, to $19.9 million for the six months ended June 30, 2025 from $11.2 million for the six months ended June 30, 2024. The increase is primarily attributable to the strategic addition of personnel and related costs of $4.9 million, certain commercial activities of $2.3 million, and other departmental overhead of $1.5 million.
Current wording
General and administrative expenses increased by $12.3 million, or 71.8%, to $29.5 million for the nine months ended September 30, 2025 from $17.2 million for the nine months ended September 30, 2024. The increase is primarily attributable to the strategic addition of personnel and related costs of $7.8 million, certain commercial activities of $2.5 million, and other departmental overhead of $2.0 million.
Previous wording
Other income, net decreased by $0.2 million to $2.8 million for the six months ended June 30, 2025 from $3.1 million for the six months ended June 30, 2024. The decrease is primarily related to a loss on extinguishment of debt partially offset by a gain on foreign currency translation rates.
Current wording
Other income, net decreased by $1.7 million to $3.5 million for the nine months ended September 30, 2025 from $5.2 million for the nine months ended September 30, 2024. The decrease is primarily related to lower interest rates and loss on extinguishment of debt, partially offset by a gain on foreign currency translation rates.
Previous wording
As of June 30, 2025, we had $17.4 million of cash and cash equivalents, $129.0 million in short-term investments, and an accumulated deficit of approximately $546.3 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 provides for a loan facility of up to $200 million. Proceeds from the initial $30 million tranche drawn under the Hercules Loan Agreement were used to repay all outstanding obligations under the SVB Loan, with a carrying value of $26.7 million, to 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 to fund our ongoing business operations including the development, regulatory approval, marketing and commercialization of MOLBREEVI.
Current wording
As of September 30, 2025, we had $16.3 million of cash and cash equivalents, $108.1 million in short-term investments, and an accumulated deficit of approximately $575.9 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 provides for a loan facility of up to $200 million. Proceeds from the initial $30 million tranche drawn under the Hercules Loan Agreement, with a carrying value of $29.8 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 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
Further, 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.
Current wording
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.
Previous wording
We have used and intend to use our liquidity and capital 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 our product candidate and general and administrative expenses. As we continue to progress on the IMPALA-2 trial, pursue regulatory approval, and invest in pre-commercial activities, we will continue to monitor our liquidity and capital requirements.
Current wording
We have used and intend to use our liquidity and capital 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.
Previous wording
Cash used in operating activities for the six months ended June 30, 2025 was $53.5 million, consisting of a net loss of $57.0 million and net $1.0 million in changes due to operating assets and liabilities. This was partially offset by approximately $4.5 million of net noncash charges (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).
Current wording
Cash used in operating activities for the nine months ended September 30, 2025 was $76.0 million, consisting of a net loss of $86.6 million offset by $2.8 million in changes to operating assets and liabilities and $7.8 million of net noncash charges. 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.
Previous wording
Cash used in investing activities of $53.7 million for the six months ended June 30, 2025 was primarily associated with proceeds from maturities of short-term investments partially offset by purchases of short-term investments.
Current wording
Cash used in investing activities of $75.1 million for the nine months ended September 30, 2025 was primarily associated with proceeds from maturities of short-term investments partially offset by purchases of short-term investments.
Previous wording
Cash provided by financing activities of $2.3 million for the six months ended June 30, 2025 was primarily the result of net proceeds from the Hercules Loan Agreement partially offset by repayment of the SVB Loan.
Current wording
Cash provided by financing activities of $2.2 million for the nine months ended September 30, 2025 was primarily the result of net proceeds from the Hercules Loan Agreement partially offset by repayment of the SVB Loan.
Previous wording
As of June 30, 2025, we had cash, cash equivalents, and short-term investments of approximately $146.4 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. The amount and timing of our future funding requirements will depend on many factors, including the pace and results of our clinical development efforts. 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 September 30, 2025, we had cash, cash equivalents, and short-term investments of approximately $124.4 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. For instance, we completed the October 2025 Offering which resulted in net proceeds to the Company of approximately $140.0 million, after deducting final underwriting discounts, commissions, and other estimated offering expenses and including the underwriter's option to purchase additional shares of our common stock at the public offering price.
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 six months ended June 30, 2025 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, 2024.
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 nine months ended September 30, 2025 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, 2024.
Rearranged current paragraphs (1)
Current report — wording carried from elsewhere
The amount and timing of our future funding requirements will depend on many factors, including the pace and results of our clinical development efforts. 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.
Rearranged previous paragraphs (1)
Previous report — wording carried elsewhere
The RTF does not impact previous designations granted by regulators for MOLBREEVI in autoimmune PAP. 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).