SVRA
SavaraCDocument history
Earnings documents stored for SVRA.
Investor releaseQuarter not tagged2026-08-24Savara Announces Encore Presentations of Results from the Phase 3 Clinical Trial of Molgramostim Inhalation Solution (Molgramostim) in Autoimmune Pulmonary Alveolar Proteinosis (APAP) at the European Respiratory Society (ERS) Congress 2026
Business Wire
Savara Announces Encore Presentations of Results from the Phase 3 Clinical Trial of Molgramostim Inhalation Solution (Molgramostim) in Autoimmune Pulmonary Alveolar Proteinosis (APAP) at the European Respiratory Society (ERS) Congress 2026
-- Company to Host Industry Evening Mini-Symposium on aPAP with Renowned Key Opinion Leaders -- YARDLEY, Pa., August 24, 2026--(BUSINESS WIRE)--Savara Inc. (Nasdaq: SVRA), a clinical stage biopharmaceutical company focused on rare respiratory diseases, announced the acceptance of one oral presentation and two poster presentations on data from the Phase 3 IMPALA-2 clinical trial at the ERS Congress in Barcelona, Spain, September 5-9, 2026. "Collectively, these data show that molgramostim continues to improve lung function, exercise capacity, and quality of life in patients, while reductions in biomarkers of aPAP lung disease severity suggest it may normalize the underlying pathobiology," said Bruce C. Trapnell, M.D., Professor of Medicine and Pediatrics at the University of Cincinnati College of Medicine and the Lead Clinical Investigator of the IMPALA-2 clinical trial. "Combined with the high retention rate in the trial and durability of effect we've now seen through the first 48-weeks of the IMPALA-2 open-label period, these results strongly support molgramostim’s potential as an effective long-term option for a patient population with no approved pharmacologic treatments. We look forward to sharing these data at the ERS Congress." Oral Presentation Title: Molgramostim for the treatment of patients with autoimmune pulmonary alveolar proteinosis (aPAP): long-term efficacy and safety results from the open-label period of the IMPALA-2 phase 3 clinical trialPresentation Number: OA2381Session: 3J – Clinical and scientific advances in rare lung diseasesDate/Time: Sunday, September 6, 2026, 3:45 – 5:00 PM CESTLocation: Fira Gran Via (Hall 3)Presenter: Bruce C. Trapnell, M.D., Professor of Medicine and Pediatrics, University of Cincinnati College of Medicine, Cincinnati, OH, United States Poster Presentations Title: Molgramostim improves exercise capacity, distance walked, and duration of exercise in patients with autoimmune pulmonary alveolar proteinosis (aPAP): results from the IMPALA-2 Phase 3 clinical trialPoster Number: PA885Session: PS-37 – Alveolar-filling disorders and autoimmune lung diseaseDate/Time: Sunday, September 6, 2026, 8:00 – 9:30 AM CESTLocation: Fira Gran Via (Hall 1)Presenter: Cormac McCarthy, M.D., Ph.D., FRCPI, Associate Professor of Medicine, University College Dublin (UCD) and Consultant Respiratory Physician, St. Vincent’s University Hospi…Read full documentShow less
-- Company to Host Industry Evening Mini-Symposium on aPAP with Renowned Key Opinion Leaders -- YARDLEY, Pa., August 24, 2026--(BUSINESS WIRE)--Savara Inc. (Nasdaq: SVRA), a clinical stage biopharmaceutical company focused on rare respiratory diseases, announced the acceptance of one oral presentation and two poster presentations on data from the Phase 3 IMPALA-2 clinical trial at the ERS Congress in Barcelona, Spain, September 5-9, 2026. "Collectively, these data show that molgramostim continues to improve lung function, exercise capacity, and quality of life in patients, while reductions in biomarkers of aPAP lung disease severity suggest it may normalize the underlying pathobiology," said Bruce C. Trapnell, M.D., Professor of Medicine and Pediatrics at the University of Cincinnati College of Medicine and the Lead Clinical Investigator of the IMPALA-2 clinical trial. "Combined with the high retention rate in the trial and durability of effect we've now seen through the first 48-weeks of the IMPALA-2 open-label period, these results strongly support molgramostim’s potential as an effective long-term option for a patient population with no approved pharmacologic treatments. We look forward to sharing these data at the ERS Congress." Oral Presentation Title: Molgramostim for the treatment of patients with autoimmune pulmonary alveolar proteinosis (aPAP): long-term efficacy and safety results from the open-label period of the IMPALA-2 phase 3 clinical trialPresentation Number: OA2381Session: 3J – Clinical and scientific advances in rare lung diseasesDate/Time: Sunday, September 6, 2026, 3:45 – 5:00 PM CESTLocation: Fira Gran Via (Hall 3)Presenter: Bruce C. Trapnell, M.D., Professor of Medicine and Pediatrics, University of Cincinnati College of Medicine, Cincinnati, OH, United States Poster Presentations Title: Molgramostim improves exercise capacity, distance walked, and duration of exercise in patients with autoimmune pulmonary alveolar proteinosis (aPAP): results from the IMPALA-2 Phase 3 clinical trialPoster Number: PA885Session: PS-37 – Alveolar-filling disorders and autoimmune lung diseaseDate/Time: Sunday, September 6, 2026, 8:00 – 9:30 AM CESTLocation: Fira Gran Via (Hall 1)Presenter: Cormac McCarthy, M.D., Ph.D., FRCPI, Associate Professor of Medicine, University College Dublin (UCD) and Consultant Respiratory Physician, St. Vincent’s University Hospital, Dublin, Ireland Title: Biomarker levels in patients with autoimmune pulmonary alveolar proteinosis (aPAP): results from the IMPALA-2 phase 3 clinical trialPoster Number: PA886Session: PS-37 – Alveolar-filling disorders and autoimmune lung diseaseDate/Time: Sunday, September 6, 2026, 8:00 – 9:30 AM CESTLocation: Fira Gran Via (Hall 1)Presenter: Yoshikazu Inoue, M.D., Ph.D., Executive Director of the Clinical Research Center, NHO Kinki Chuo Chest Medical Center and Internal Medicine, Osaka Anti-Tuberculosis Association Osaka Fukujuji Hospital, Osaka, Japan Industry Evening Mini-Symposium Title: Autoimmune Pulmonary Alveolar Proteinosis: From Disease Mechanisms to Clinical ManagementDate/Time: Sunday, September 6, 2026, 5:30 – 7:00 PM CESTLocation: Fira Gran Via (Room 3M)Chair: Cormac McCarthy, M.D., Ph.D., FRCPI, Associate Professor of Medicine, University College Dublin (UCD) and Consultant Respiratory Physician, St. Vincent’s University Hospital, Dublin, IrelandSpeakers: Ilaria Campo, Ph.D., SSD Patologia e Genetica Molecolare-SC Pneumologia, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy; Marcel Veltkamp, M.D., Ph.D., ILD Center of Excellence, Department of Pulmonology, St. Antonius Hospital, Nieuwegein, the Netherlands, Division of Heart & Lungs, University Medical Center, Utrecht, the Netherlands; and Stéphane Jouneau M.D., Ph.D., Service de Pneumologie, Centre de Référence Constitutif pour les Maladies Rares Pulmonaires, CHU de Rennes, IRSET UMR 1085, Université de Rennes, France About Autoimmune Pulmonary Alveolar Proteinosis (aPAP) Autoimmune PAP is a rare lung disease characterized by the abnormal build-up of surfactant in the alveoli. Surfactant consists of proteins and lipids and is an important physiological substance that lines the alveoli to prevent them from collapsing. In a healthy lung, excess surfactant is cleared and digested by immune cells called alveolar macrophages. Alveolar macrophages need to be stimulated by granulocyte-macrophage colony-stimulating factor (GM-CSF) to function properly in clearing surfactant, but in aPAP, GM-CSF is neutralized by antibodies against GM-CSF, rendering macrophages unable to adequately clear surfactant. As a result, an excess of surfactant accumulates in the alveoli, causing impaired gas transfer, resulting in clinical symptoms of shortness of breath, often with cough and frequent fatigue. Patients may also experience episodes of fever, chest pain, or coughing up blood, especially if secondary lung infection develops. In the long term, the disease can lead to serious complications, including lung fibrosis and the need for a lung transplant. About Savara Savara is a clinical stage biopharmaceutical company focused on rare respiratory diseases. Our lead program, molgramostim inhalation solution (molgramostim) is a recombinant human granulocyte-macrophage colony-stimulating factor (GM-CSF) in Phase 3 development for autoimmune pulmonary alveolar proteinosis (aPAP). Molgramostim is delivered via a proprietary investigational eFlow® Nebulizer System (PARI Pharma GmbH) specifically developed for inhalation of molgramostim. Our management team has significant experience in rare respiratory diseases and pulmonary medicine, identifying unmet needs, and effectively advancing product candidates to approval and commercialization. More information can be found at www.savarapharma.com and LinkedIn. Forward-Looking Statements Savara cautions you that statements in this press release that are not a description of historical fact are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements may be identified by the use of words referencing future events or circumstances such as "expect," "intend," "plan," "anticipate," "believe," and "will," among others. Such statements include statements that the results strongly support molgramostim’s potential as an effective long-term option for a patient population with no approved pharmacologic treatments. These forward-looking statements are based upon Savara’s current expectations and involve assumptions that may never materialize or may prove to be incorrect. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements due to various risks and uncertainties, which include, without limitation, the risks associated with our ability to successfully develop, obtain regulatory approval for, and commercialize molgramostim for autoimmune PAP; changes to applicable laws and regulations; the availability of sufficient resources for Savara’s operations and planned clinical development programs; and the timing and ability of Savara to raise additional capital as needed to fund continued operations. All forward-looking statements are expressly qualified in their entirety by these cautionary statements. For a detailed description of our risks and uncertainties, you are encouraged to review our documents filed with the SEC including our recent filings on Form 8-K, Form 10-K and Form 10-Q. You are cautioned not to place undue reliance on forward-looking statements, which speak only as of the date on which they were made. Savara undertakes no obligation to update such statements, except as may be required by law. View source version on businesswire.com: https://www.businesswire.com/news/home/20260824428528/en/ Contacts Media and Investor Contact:Savara Inc.Temre Johnson, Executive Director, Corporate [email protected]
Investor releaseQuarter not tagged2026-08-11Savara Reports Second Quarter 2026 Financial Results and Provides Business Update
Business Wire
Savara Reports Second Quarter 2026 Financial Results and Provides Business Update
MOLBREEVI* BLA PDUFA Target Action Date Set for November 22, 2026 MOLBREEVI MAAs Under Review by the EMA and the U.K.’s MHRA; Decisions Expected in Q1 2027 and Q4 2026, respectively Data Presented at ATS Showed Molgramostim Demonstrated Continuous Long-term Improvements in Lung Function and Respiratory Health-Related Quality of Life European and Australian Patent Offices Granted MOLBREEVI Liquid Formulation Patents, Providing Protection until March 2041 ~$173M in Cash and Short-Term Investments as of June 30, 2026, Plus up to ~$150M of Non-Dilutive Capital Upon FDA Approval of MOLBREEVI, Positions the Company Well for Launch LANGHORNE, Pa., August 11, 2026--(BUSINESS WIRE)--Savara Inc. (Nasdaq: SVRA) (the Company), a clinical stage biopharmaceutical company focused on rare respiratory diseases, reported financial results for the second quarter ending June 30, 2026 and provided a business update. "While we have regulatory applications under review across the U.S., EU, and U.K., the U.S. represents our nearest-term opportunity," said Matt Pauls, J.D., M.B.A., Chair and Chief Executive Officer, Savara. "Our focus is on the potential launch of MOLBREEVI in the U.S., supported by a strong balance sheet to ensure commercial readiness." Second Quarter Financial Results (Unaudited) Savara's net loss for the second quarter of 2026 was $40.2 million, or $(0.16) per share of which $7.8 million was related to non-cash share-based compensation expense compared with a net loss of $30.4 million, or $(0.14) per share of which $2.7 million was related to share-based compensation expense, for the second quarter of 2025. 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. This 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 included 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 and quality assurance consulting. General and administrative expenses increased by $8.3 million, or 78.2%, to $19…Read full documentShow less
MOLBREEVI* BLA PDUFA Target Action Date Set for November 22, 2026 MOLBREEVI MAAs Under Review by the EMA and the U.K.’s MHRA; Decisions Expected in Q1 2027 and Q4 2026, respectively Data Presented at ATS Showed Molgramostim Demonstrated Continuous Long-term Improvements in Lung Function and Respiratory Health-Related Quality of Life European and Australian Patent Offices Granted MOLBREEVI Liquid Formulation Patents, Providing Protection until March 2041 ~$173M in Cash and Short-Term Investments as of June 30, 2026, Plus up to ~$150M of Non-Dilutive Capital Upon FDA Approval of MOLBREEVI, Positions the Company Well for Launch LANGHORNE, Pa., August 11, 2026--(BUSINESS WIRE)--Savara Inc. (Nasdaq: SVRA) (the Company), a clinical stage biopharmaceutical company focused on rare respiratory diseases, reported financial results for the second quarter ending June 30, 2026 and provided a business update. "While we have regulatory applications under review across the U.S., EU, and U.K., the U.S. represents our nearest-term opportunity," said Matt Pauls, J.D., M.B.A., Chair and Chief Executive Officer, Savara. "Our focus is on the potential launch of MOLBREEVI in the U.S., supported by a strong balance sheet to ensure commercial readiness." Second Quarter Financial Results (Unaudited) Savara's net loss for the second quarter of 2026 was $40.2 million, or $(0.16) per share of which $7.8 million was related to non-cash share-based compensation expense compared with a net loss of $30.4 million, or $(0.14) per share of which $2.7 million was related to share-based compensation expense, for the second quarter of 2025. 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. This 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 included 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 and quality assurance consulting. General and administrative expenses increased by $8.3 million, or 78.2%, to $19.0 million for the three months ended June 30, 2026 from $10.7 million for the three months ended June 30, 2025. The increase was primarily attributable to $7.5 million higher personnel costs, driven by increased stock-based compensation expense as well as increased headcount as we build out our commercial team in support of our planned product launch, in addition to an increase of $0.8 million in certain commercial activities. These investments reflect our strategy to establish the commercial infrastructure necessary to support an effective and timely launch. As of June 30, 2026, the Company had cash, cash equivalents and short-term investments of ~$173.0 million and debt of ~$30.1 million. About Autoimmune Pulmonary Alveolar Proteinosis (Autoimmune PAP) Autoimmune PAP is a rare lung disease characterized by the abnormal build-up of surfactant in the alveoli. Surfactant consists of proteins and lipids and is an important physiological substance that lines the alveoli to prevent them from collapsing. In a healthy lung, excess surfactant is cleared and digested by immune cells called alveolar macrophages. Alveolar macrophages need to be stimulated by granulocyte-macrophage colony-stimulating factor (GM-CSF) to function properly in clearing surfactant, but in autoimmune PAP, GM-CSF is neutralized by autoantibodies against GM-CSF, rendering macrophages unable to adequately clear surfactant. As a result, an excess of surfactant accumulates in the alveoli, causing impaired gas transfer, resulting in clinical symptoms of shortness of breath, often with cough and frequent fatigue. Patients may also experience episodes of fever, chest pain, or coughing up blood, especially if secondary lung infection develops. In the long term, the disease can lead to serious complications, including lung fibrosis and the need for a lung transplant. About Savara Savara is a clinical-stage biopharmaceutical company focused on rare respiratory diseases. Our lead program, MOLBREEVI*, is a recombinant human granulocyte-macrophage colony-stimulating factor (GM-CSF) in Phase 3 development for autoimmune pulmonary alveolar proteinosis (autoimmune PAP). MOLBREEVI is delivered via an investigational eFlow® Nebulizer System (PARI Pharma GmbH) specifically developed for inhalation of a large molecule. Our management team has significant experience in rare respiratory diseases and pulmonary medicine, identifying unmet needs, and effectively advancing product candidates to approval and commercialization. More information can be found at www.savarapharma.com and LinkedIn. *MOLBREEVI is the proposed trade name for molgramostim inhalation solution. It is not approved in any indication. MOLBREEVI is a trademark of Savara Inc. Forward-Looking Statements Savara cautions you that statements in this press release that are not a description of historical fact are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements may be identified by the use of words referencing future events or circumstances such as "expect," "intend," "plan," "anticipate," "believe," and "will," among others. Such statements include, but are not limited to, statements related to the PDUFA target action date, the timing of regulatory actions by the EMA and MHRA, the duration of patent protection, that Savara has access to up to ~$150M of non-dilutive capital upon FDA approval of MOLBREEVI, that the U.S. represents our nearest-term opportunity, and that our focus is on the potential launch of MOLBREEVI in the U.S., supported by a strong balance sheet to ensure commercial readiness. Savara may not actually achieve any of the matters referred to in such forward-looking statements, and you should not place undue reliance on these forward-looking statements. These forward-looking statements are based upon Savara’s current expectations and involve assumptions that may never materialize or may prove to be incorrect. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties, which include, without limitation, the risks associated with our ability to successfully develop, obtain regulatory approval for, and commercialize MOLBREEVI for autoimmune PAP; changes to applicable laws and regulations; the ability to project future cash utilization and reserves needed for contingent future liabilities and business operations; the availability of sufficient resources for Savara’s operations and to conduct or continue planned clinical development programs; and the timing and ability of Savara to raise additional capital as needed to fund continued operations. All forward-looking statements are expressly qualified in their entirety by these cautionary statements. For a detailed description of our risks and uncertainties, you are encouraged to review our documents filed with the SEC including our recent filings on Form 8-K, Form 10-K and Form 10-Q. You are cautioned not to place undue reliance on forward-looking statements, which speak only as of the date on which they were made. Savara undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as may be required by law. Financial Information to Follow View source version on businesswire.com: https://www.businesswire.com/news/home/20260811733978/en/ Contacts Media and Investor Relations Contact Savara Inc.Temre Johnson, Executive Director, Corporate [email protected]
Investor releaseQuarter not tagged2026-05-22Savara Inc. (SVRA) Reports Q1 Financial Results
Insider Monkey
Savara Inc. (SVRA) Reports Q1 Financial Results
Savara Inc. (NASDAQ:SVRA) is one of the 10 Best Penny Stocks to Buy for Long Term. On May 12, 2026, Savara Inc. (NASDAQ:SVRA) reported Q1 EPS of (15c), versus the consensus estimate of (14c). Chair and CEO Matt Pauls said the company ended the quarter with approximately $203M in cash and expects to have access to as much as $150M in additional non-dilutive funding through debt and royalty financing structures if MOLBREEVI receives approval. Management said this positions the company to support global commercial launch activities. Pauls added that preparations ahead of the November 22 PDUFA date are accelerating, with the company’s Rare Disease Specialist team already focused on increasing awareness of autoimmune PAP and advancing launch readiness for MOLBREEVI, which could become the first approved treatment for the disease. Copyright: djoronimo / 123RF Stock Photo Last month, Oppenheimer analyst Mazahir Alimohamed assumed coverage of Savara Inc. (NASDAQ:SVRA) with an Outperform rating and raised the firm’s price target to $11 from $9. The firm said the company’s investment story is increasingly centered on regulatory execution and commercialization following the FDA’s Priority Review for the BLA submission of molgramostim, an inhaled GM-CSF therapy. Oppenheimer added that data from the Phase 3 IMPALA-2 study in autoimmune PAP support a high-probability approval outlook, noting that prior FDA feedback was primarily related to chemistry, manufacturing, and controls. Savara Inc. (NASDAQ:SVRA) is a clinical-stage biopharmaceutical company focused on therapies for rare respiratory diseases. While we acknowledge the potential of SVRA as an investment, we believe certain AI stocks offer greater upside potential and carry less downside risk. If you're looking for an extremely undervalued AI stock that also stands to benefit significantly from Trump-era tariffs and the onshoring trend, see our free report on the best short-term AI stock. READ NEXT: 33 Stocks That Should Double in 3 Years and Cathie Wood 2026 Portfolio: 10 Best Stocks to Buy. Disclosure: None. Follow Insider Monkey on Google News.
Investor releaseQuarter not tagged2026-05-12Savara Reports First Quarter Financial Results and Provides Business Update
Business Wire
Savara Reports First Quarter Financial Results and Provides Business Update
Achieved Regulatory Milestones for the MOLBREEVI* Development Program in Autoimmune Pulmonary Alveolar Proteinosis (Autoimmune PAP): Biologics License Application (BLA) Filed by the U.S. Food & Drug Administration (FDA), Prescription Drug User Fee Act (PDUFA) Target Action Date is November 22, 2026 Marketing Authorization Applications (MAAs) Validated by the European Medicines Agency (EMA) and the U.K. Medicines and Healthcare Products Regulatory Agency (MHRA) with Decisions Expected in Q1 2027 and Q4 2026, respectively Announced New Data from the Phase 3 IMPALA-2 Clinical Trial Will be Presented at the American Thoracic Society (ATS) International Conference in May, Including Data from the Ongoing Open-Label Treatment Period With ~$203M in Cash and Short-Term Investments as of March 31, 2026, and Access to up to an Additional ~$150M of Non-Dilutive Capital upon FDA Approval of MOLBREEVI, the Company Remains Well Capitalized for Launch LANGHORNE, Pa., May 12, 2026--(BUSINESS WIRE)--Savara Inc. (Nasdaq: SVRA) (the Company), a clinical stage biopharmaceutical company focused on rare respiratory diseases, reported financial results for the first quarter ending March 31, 2026 and provided a business update. "With approximately $203 million in cash and, upon MOLBREEVI approval, access to up to an additional $150 million in non-dilutive capital through debt and royalty structures, we remain well capitalized to fund global commercial launch preparations," said Matt Pauls, Chair and CEO, Savara. "With a PDUFA action date of November 22nd, U.S. commercial planning momentum is building. Our newly deployed Rare Disease Specialists are actively driving disease awareness for autoimmune PAP and advancing launch readiness initiatives for MOLBREEVI—a potentially first and only treatment for autoimmune PAP." First Quarter Financial Results Savara's net loss for the first quarter of 2026 was $37.3 million, or $(0.15) per share of which $10.7 million was related to non-cash share based compensation expense, specifically $7.8 million attributed to performance stock units, compared with a net loss of $26.6 million, or $(0.12) per share of which $3.0 million was related to share based compensation expense, for the first quarter of 2025. 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 $…Read full documentShow less
Achieved Regulatory Milestones for the MOLBREEVI* Development Program in Autoimmune Pulmonary Alveolar Proteinosis (Autoimmune PAP): Biologics License Application (BLA) Filed by the U.S. Food & Drug Administration (FDA), Prescription Drug User Fee Act (PDUFA) Target Action Date is November 22, 2026 Marketing Authorization Applications (MAAs) Validated by the European Medicines Agency (EMA) and the U.K. Medicines and Healthcare Products Regulatory Agency (MHRA) with Decisions Expected in Q1 2027 and Q4 2026, respectively Announced New Data from the Phase 3 IMPALA-2 Clinical Trial Will be Presented at the American Thoracic Society (ATS) International Conference in May, Including Data from the Ongoing Open-Label Treatment Period With ~$203M in Cash and Short-Term Investments as of March 31, 2026, and Access to up to an Additional ~$150M of Non-Dilutive Capital upon FDA Approval of MOLBREEVI, the Company Remains Well Capitalized for Launch LANGHORNE, Pa., May 12, 2026--(BUSINESS WIRE)--Savara Inc. (Nasdaq: SVRA) (the Company), a clinical stage biopharmaceutical company focused on rare respiratory diseases, reported financial results for the first quarter ending March 31, 2026 and provided a business update. "With approximately $203 million in cash and, upon MOLBREEVI approval, access to up to an additional $150 million in non-dilutive capital through debt and royalty structures, we remain well capitalized to fund global commercial launch preparations," said Matt Pauls, Chair and CEO, Savara. "With a PDUFA action date of November 22nd, U.S. commercial planning momentum is building. Our newly deployed Rare Disease Specialists are actively driving disease awareness for autoimmune PAP and advancing launch readiness initiatives for MOLBREEVI—a potentially first and only treatment for autoimmune PAP." First Quarter Financial Results Savara's net loss for the first quarter of 2026 was $37.3 million, or $(0.15) per share of which $10.7 million was related to non-cash share based compensation expense, specifically $7.8 million attributed to performance stock units, compared with a net loss of $26.6 million, or $(0.12) per share of which $3.0 million was related to share based compensation expense, for the first quarter of 2025. 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 was 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. 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 was 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. As of March 31, 2026, the Company had cash, cash equivalents and short-term investments of ~$202.8 million and debt of ~$30.1 million. About Autoimmune Pulmonary Alveolar Proteinosis (Autoimmune PAP) Autoimmune PAP is a rare lung disease characterized by the abnormal build-up of surfactant in the alveoli. Surfactant consists of proteins and lipids and is an important physiological substance that lines the alveoli to prevent them from collapsing. In a healthy lung, excess surfactant is cleared and digested by immune cells called alveolar macrophages. Alveolar macrophages need to be stimulated by granulocyte-macrophage colony-stimulating factor (GM-CSF) to function properly in clearing surfactant, but in autoimmune PAP, GM-CSF is neutralized by autoantibodies against GM-CSF, rendering macrophages unable to adequately clear surfactant. As a result, an excess of surfactant accumulates in the alveoli, causing impaired gas transfer, resulting in clinical symptoms of shortness of breath, often with cough and frequent fatigue. Patients may also experience episodes of fever, chest pain, or coughing up blood, especially if secondary lung infection develops. In the long term, the disease can lead to serious complications, including lung fibrosis and the need for a lung transplant. About Savara Savara is a clinical-stage biopharmaceutical company focused on rare respiratory diseases. Our lead program, MOLBREEVI*, is a recombinant human granulocyte-macrophage colony-stimulating factor (GM-CSF) in Phase 3 development for autoimmune pulmonary alveolar proteinosis (autoimmune PAP). MOLBREEVI is delivered via an investigational eFlow® Nebulizer System (PARI Pharma GmbH) specifically developed for inhalation of a large molecule. Our management team has significant experience in rare respiratory diseases and pulmonary medicine, identifying unmet needs, and effectively advancing product candidates to approval and commercialization. More information can be found at www.savarapharma.com and LinkedIn. *MOLBREEVI is the FDA and EMA conditionally accepted trade name for molgramostim inhalation solution. It is not approved in any indication. MOLBREEVI is a trademark of Savara Inc. Forward-Looking Statements Savara cautions you that statements in this press release that are not a description of historical fact are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements may be identified by the use of words referencing future events or circumstances such as "expect," "intend," "plan," "anticipate," "believe," and "will," among others. Such statements include, but are not limited to, statements related to the PDUFA target action date, the timing of regulatory actions by the EMA and MHRA, upcoming presentations at ATS, that Savara has access to up to ~$150M of non-dilutive capital upon FDA approval of MOLBREEVI, that the Company remains well capitalized for launch, and that MOLBREEVI is a potentially first and only treatment for autoimmune PAP. Savara may not actually achieve any of the matters referred to in such forward-looking statements, and you should not place undue reliance on these forward-looking statements. These forward-looking statements are based upon Savara’s current expectations and involve assumptions that may never materialize or may prove to be incorrect. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties, which include, without limitation, the risks associated with our ability to successfully develop, obtain regulatory approval for, and commercialize MOLBREEVI for autoimmune PAP; changes to applicable laws and regulations; the ability to project future cash utilization and reserves needed for contingent future liabilities and business operations; the availability of sufficient resources for Savara’s operations and to conduct or continue planned clinical development programs; and the timing and ability of Savara to raise additional capital as needed to fund continued operations. All forward-looking statements are expressly qualified in their entirety by these cautionary statements. For a detailed description of our risks and uncertainties, you are encouraged to review our documents filed with the SEC including our recent filings on Form 8-K, Form 10-K and Form 10-Q. You are cautioned not to place undue reliance on forward-looking statements, which speak only as of the date on which they were made. Savara undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as may be required by law. View source version on businesswire.com: https://www.businesswire.com/news/home/20260512677993/en/ Contacts Media and Investor Relations Contact Savara Inc.Temre Johnson, Executive Director, Corporate [email protected]
Investor releaseQuarter not tagged2026-03-13Savara Reports Fourth Quarter and Year End 2025 Financial Results and Provides Business Update
Business Wire
Savara Reports Fourth Quarter and Year End 2025 Financial Results and Provides Business Update
Achieved Regulatory Milestones for the MOLBREEVI* in Autoimmune Pulmonary Alveolar Proteinosis (Autoimmune PAP) Development Program: U.S. Food and Drug Administration (FDA) filed the Biologics License Application (BLA) Priority Review granted, Prescription Drug User Fee Act (PDUFA) date set for August 22, 2026 FDA indicated an Advisory Committee is not planned for the BLA Submitted Marketing Authorization Applications (MAAs) to the European Medicines Agency (EMA) and the U.K. Medicines and Healthcare Products Regulatory Agency (MHRA) With ~$236M in Cash and Short-Term Investments as of December 31, 2025, and Access to up to an Additional ~$150M of Non-Dilutive Capital upon FDA Approval of MOLBREEVI, the Company is Well Capitalized for Launch LANGHORNE, Pa., March 13, 2026--(BUSINESS WIRE)--Savara Inc. (Nasdaq: SVRA) (the Company), a clinical stage biopharmaceutical company focused on rare respiratory diseases, reported financial results for the fourth quarter and full year ending December 31, 2025 and provided a business update. "Over the last year, we significantly advanced the MOLBREEVI development program," said Matt Pauls, Chair and Chief Executive Officer, Savara. "With the filing of the BLA, an assigned PDUFA date of August 22nd, and submission of the MAAs we have strong momentum. U.S. commercial planning is underway, most notably with the onboarding of a market development team that will be complete in the second quarter. With approximately $236 million in cash and access to up to an additional $150 million in non-dilutive capital through debt and royalty structures upon MOLBREEVI approval, we can fund global commercial launch activities. Strong financial flexibility combined with meaningful near-term catalysts means we enter 2026 in a position of strength and confidence." In addition to Fast Track and Breakthrough Therapy Designations, MOLBREEVI has been granted Orphan Drug Designation for the treatment of autoimmune PAP by the FDA and the EMA, as well as Innovation Passport (IP) and Promising Innovative Medicine (PIM) designations by the UK’s MHRA. Fourth Quarter Financial Results (Unaudited) Savara's net loss for the fourth quarter of 2025 was $32.2 million, or $(0.13) per share, compared with a net loss of $29.0 million, or $(0.13) per share, for the fourth quarter of 2024. Research and development expenses for the fourth quarter of 2025 and 2024…Read full documentShow less
Achieved Regulatory Milestones for the MOLBREEVI* in Autoimmune Pulmonary Alveolar Proteinosis (Autoimmune PAP) Development Program: U.S. Food and Drug Administration (FDA) filed the Biologics License Application (BLA) Priority Review granted, Prescription Drug User Fee Act (PDUFA) date set for August 22, 2026 FDA indicated an Advisory Committee is not planned for the BLA Submitted Marketing Authorization Applications (MAAs) to the European Medicines Agency (EMA) and the U.K. Medicines and Healthcare Products Regulatory Agency (MHRA) With ~$236M in Cash and Short-Term Investments as of December 31, 2025, and Access to up to an Additional ~$150M of Non-Dilutive Capital upon FDA Approval of MOLBREEVI, the Company is Well Capitalized for Launch LANGHORNE, Pa., March 13, 2026--(BUSINESS WIRE)--Savara Inc. (Nasdaq: SVRA) (the Company), a clinical stage biopharmaceutical company focused on rare respiratory diseases, reported financial results for the fourth quarter and full year ending December 31, 2025 and provided a business update. "Over the last year, we significantly advanced the MOLBREEVI development program," said Matt Pauls, Chair and Chief Executive Officer, Savara. "With the filing of the BLA, an assigned PDUFA date of August 22nd, and submission of the MAAs we have strong momentum. U.S. commercial planning is underway, most notably with the onboarding of a market development team that will be complete in the second quarter. With approximately $236 million in cash and access to up to an additional $150 million in non-dilutive capital through debt and royalty structures upon MOLBREEVI approval, we can fund global commercial launch activities. Strong financial flexibility combined with meaningful near-term catalysts means we enter 2026 in a position of strength and confidence." In addition to Fast Track and Breakthrough Therapy Designations, MOLBREEVI has been granted Orphan Drug Designation for the treatment of autoimmune PAP by the FDA and the EMA, as well as Innovation Passport (IP) and Promising Innovative Medicine (PIM) designations by the UK’s MHRA. Fourth Quarter Financial Results (Unaudited) Savara's net loss for the fourth quarter of 2025 was $32.2 million, or $(0.13) per share, compared with a net loss of $29.0 million, or $(0.13) per share, for the fourth quarter of 2024. Research and development expenses for the fourth quarter of 2025 and 2024 were $20.9 million and $23.3 million, respectively. General and administrative expenses for the fourth quarter of 2025 and 2024 were $12.5 million and $7.8 million, respectively. As of December 31, 2025, the Company had cash, cash equivalents and short-term investments of $235.7 million. Fiscal Year 2025 Financial Results The Company’s net loss for the year ended December 31, 2025 was $118.8 million, or $(0.53) per share, compared with a net loss of was $95.9 million, or $(0.48) per share for the year ended December 31, 2024. 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. This increase was 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; $0.5 million of costs related to our chemistry, manufacturing, and controls activities; and $1.0 million other departmental overhead, partially offset by a decrease of $3.8 million in clinical costs. 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. The increase was 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; certain additional commercial activities of $3.1 million; and other overhead of $2.7 million primarily driven by expanded patient advocacy and medical affairs activities. About Autoimmune Pulmonary Alveolar Proteinosis (Autoimmune PAP) Autoimmune PAP is a rare lung disease characterized by the abnormal build-up of surfactant in the alveoli. Surfactant consists of proteins and lipids and is an important physiological substance that lines the alveoli to prevent them from collapsing. In a healthy lung, excess surfactant is cleared and digested by immune cells called alveolar macrophages. Alveolar macrophages need to be stimulated by granulocyte-macrophage colony-stimulating factor (GM-CSF) to function properly in clearing surfactant, but in autoimmune PAP, GM-CSF is neutralized by autoantibodies against GM-CSF, rendering macrophages unable to adequately clear surfactant. As a result, an excess of surfactant accumulates in the alveoli, causing impaired gas transfer, resulting in clinical symptoms of shortness of breath, often with cough and frequent fatigue. Patients may also experience episodes of fever, chest pain, or coughing up blood, especially if secondary lung infection develops. In the long term, the disease can lead to serious complications, including lung fibrosis and the need for a lung transplant. About Savara Savara is a clinical-stage biopharmaceutical company focused on rare respiratory diseases. Our lead program, MOLBREEVI*, is a recombinant human granulocyte-macrophage colony-stimulating factor (GM-CSF) in Phase 3 development for autoimmune pulmonary alveolar proteinosis (autoimmune PAP). MOLBREEVI is delivered via an investigational eFlow® Nebulizer System (PARI Pharma GmbH) specifically developed for inhalation of a large molecule. Our management team has significant experience in rare respiratory diseases and pulmonary medicine, identifying unmet needs, and effectively advancing product candidates to approval and commercialization. More information can be found at www.savarapharma.com and LinkedIn. *MOLBREEVI is the FDA and EMA conditionally accepted trade name for molgramostim inhalation solution. It is not approved in any indication. MOLBREEVI is a trademark of Savara Inc. Forward-Looking Statements Savara cautions you that statements in this press release that are not a description of historical fact are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements may be identified by the use of words referencing future events or circumstances such as "expect," "intend," "plan," "anticipate," "believe," and "will," among others. Such statements include, but are not limited to, statements related to the timing of the PDUFA date and potential FDA approval for MOLBREEVI, that Savara has access to up to ~$150M of non-dilutive capital upon FDA approval of MOLBREEVI, that the Company is well capitalized for launch and can fund global launch activities, and that onboarding of a market development team that will be complete in the second quarter. Savara may not actually achieve any of the matters referred to in such forward-looking statements, and you should not place undue reliance on these forward-looking statements. These forward-looking statements are based upon Savara’s current expectations and involve assumptions that may never materialize or may prove to be incorrect. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties, which include, without limitation, the risks associated with our ability to successfully develop, obtain regulatory approval for, and commercialize MOLBREEVI for autoimmune PAP; changes to applicable laws and regulations; the ability to project future cash utilization and reserves needed for contingent future liabilities and business operations; the availability of sufficient resources for Savara’s operations and to conduct or continue planned clinical development programs; and the timing and ability of Savara to raise additional capital as needed to fund continued operations. All forward-looking statements are expressly qualified in their entirety by these cautionary statements. For a detailed description of our risks and uncertainties, you are encouraged to review our documents filed with the SEC including our recent filings on Form 8-K, Form 10-K and Form 10-Q. You are cautioned not to place undue reliance on forward-looking statements, which speak only as of the date on which they were made. Savara undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as may be required by law. Financial Information to Follow View source version on businesswire.com: https://www.businesswire.com/news/home/20260313815938/en/ Contacts Media and Investor Relations Contact Savara Inc. Temre Johnson, Executive Director, Corporate Affairs [email protected]
Investor releaseQuarter not tagged2025-11-13Savara Reports Third Quarter 2025 Financial Results and Provides Business Update
Business Wire
Savara Reports Third Quarter 2025 Financial Results and Provides Business Update
-- On Track to Resubmit the Biologics License Application (BLA) for MOLBREEVI* in Autoimmune Pulmonary Alveolar Proteinosis (Autoimmune PAP) in December and Will Request Priority Review -- -- Expect to Submit the MOLBREEVI Marketing Authorization Applications (MAA) for Autoimmune PAP to the European Medicines Agency (EMA) and the UK Medicines and Healthcare Products Regulatory Agency (MHRA) in 1Q 2026 -- -- Recently Strengthened Balance Sheet with ~$149.5M Equity Financing, Which Added ~$140M to the ~$124M in Cash, Cash Equivalents, and Short-Term Investments Reported as of September 30, 2025, and Announced $75M Royalty Funding Agreement to Support Potential MOLBREEVI Launch -- LANGHORNE, Pa., November 12, 2025--(BUSINESS WIRE)--Savara Inc. (Nasdaq: SVRA) (the Company), a clinical stage biopharmaceutical company focused on rare respiratory diseases, reported financial results for the third quarter ending September 30, 2025. "Our recent strategic financings further strengthen our balance sheet, significantly increase our cash runway, and allow us to accelerate our investment in preparing for the potential commercialization of MOLBREEVI," said Matt Pauls, J.D., M.B.A., Chair and Chief Executive Officer, Savara. "We remain on track to resubmit the MOLBREEVI BLA in December as well as submit the MAAs for MOLBREEVI in Europe and the UK in the first quarter of 2026." Pauls continued, "At this year’s European Respiratory Society meeting we presented new data analyses from the pivotal IMPALA-2 trial that further support the efficacy of MOLBREEVI for the treatment of autoimmune PAP. Given that there are no approved therapies for autoimmune PAP in the U.S. or Europe, we are steadfast in our goal to bring the first and only pharmacologic treatment for autoimmune PAP to market and are confident that MOLBREEVI could fundamentally change the way this rare and chronic lung disease is treated." Third Quarter Financial Results (Unaudited) Savara's net loss for the third quarter of 2025 was $29.6 million, or $(0.14) per share, compared with a net loss of $24.2 million, or $(0.11) per share, for the third quarter of 2024. 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 was primarily due to the performance of tasks…Read full documentShow less
-- On Track to Resubmit the Biologics License Application (BLA) for MOLBREEVI* in Autoimmune Pulmonary Alveolar Proteinosis (Autoimmune PAP) in December and Will Request Priority Review -- -- Expect to Submit the MOLBREEVI Marketing Authorization Applications (MAA) for Autoimmune PAP to the European Medicines Agency (EMA) and the UK Medicines and Healthcare Products Regulatory Agency (MHRA) in 1Q 2026 -- -- Recently Strengthened Balance Sheet with ~$149.5M Equity Financing, Which Added ~$140M to the ~$124M in Cash, Cash Equivalents, and Short-Term Investments Reported as of September 30, 2025, and Announced $75M Royalty Funding Agreement to Support Potential MOLBREEVI Launch -- LANGHORNE, Pa., November 12, 2025--(BUSINESS WIRE)--Savara Inc. (Nasdaq: SVRA) (the Company), a clinical stage biopharmaceutical company focused on rare respiratory diseases, reported financial results for the third quarter ending September 30, 2025. "Our recent strategic financings further strengthen our balance sheet, significantly increase our cash runway, and allow us to accelerate our investment in preparing for the potential commercialization of MOLBREEVI," said Matt Pauls, J.D., M.B.A., Chair and Chief Executive Officer, Savara. "We remain on track to resubmit the MOLBREEVI BLA in December as well as submit the MAAs for MOLBREEVI in Europe and the UK in the first quarter of 2026." Pauls continued, "At this year’s European Respiratory Society meeting we presented new data analyses from the pivotal IMPALA-2 trial that further support the efficacy of MOLBREEVI for the treatment of autoimmune PAP. Given that there are no approved therapies for autoimmune PAP in the U.S. or Europe, we are steadfast in our goal to bring the first and only pharmacologic treatment for autoimmune PAP to market and are confident that MOLBREEVI could fundamentally change the way this rare and chronic lung disease is treated." Third Quarter Financial Results (Unaudited) Savara's net loss for the third quarter of 2025 was $29.6 million, or $(0.14) per share, compared with a net loss of $24.2 million, or $(0.11) per share, for the third quarter of 2024. 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 was primarily due to the performance of tasks related to our MOLBREEVI program, which included approximately $0.3 million of costs related to our chemistry, manufacturing, and controls activities, primarily driven by initiatives to establish our primary 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. 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 was 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. As of September 30, 2025, the Company had cash, cash equivalents and short-term investments of ~$124.4 million and debt of ~$29.8 million. Proceeds from our recently completed public offering of common stock strengthened the Company’s balance sheet by approximately $140 million. About Autoimmune Pulmonary Alveolar Proteinosis (Autoimmune PAP) Autoimmune PAP is a rare lung disease characterized by the abnormal build-up of surfactant in the alveoli of the lungs. Surfactant consists of proteins and lipids and is an important physiological substance that lines the alveoli to prevent them from collapsing. In a healthy lung, excess surfactant is cleared and digested by immune cells called alveolar macrophages. Alveolar macrophages need to be stimulated by granulocyte-macrophage colony stimulating factor (GM-CSF) to function properly in clearing surfactant, but in autoimmune PAP, GM-CSF is neutralized by antibodies against GM-CSF, rendering macrophages unable to adequately clear surfactant. As a result, an excess of surfactant accumulates in the alveoli, causing impaired gas exchange, resulting in clinical symptoms of shortness of breath, often with cough and frequent fatigue. Patients may also experience episodes of fever, chest pain, or coughing up blood, especially if secondary lung infection develops. In the long term, the disease can lead to serious complications, including lung fibrosis and the need for a lung transplant. About Savara Savara is a clinical stage biopharmaceutical company focused on rare respiratory diseases. Our lead program, MOLBREEVI*, is a recombinant human granulocyte-macrophage colony-stimulating factor (GM-CSF) in Phase 3 development for autoimmune pulmonary alveolar proteinosis (autoimmune PAP). MOLBREEVI is delivered via a proprietary investigational eFlow® Nebulizer System (PARI Pharma GmbH) specifically developed for inhalation of MOLBREEVI. Our management team has significant experience in rare respiratory diseases and pulmonary medicine, identifying unmet needs, and effectively advancing product candidates to approval and commercialization. More information can be found at www.savarapharma.com and LinkedIn. *MOLBREEVI is the FDA and EMA conditionally accepted trade name for molgramostim inhalation solution. It is not approved in any indication. MOLBREEVI is a trademark of Savara Inc. Forward-Looking Statements Savara cautions you that statements in this press release that are not descriptions of historical fact are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements may be identified by the use of words referencing future events or circumstances such as "expect," "intend," "plan," "anticipate," "believe," "could" and "will," among others. Such statements include, but are not limited to, statements related to the expected timing for resubmission of the BLA and our plan to request priority review, the anticipated timing of the MAA submissions to the EMA and MHRA, statements regarding our intentions to use net proceeds from our recent equity offering to accelerate our investment in preparing for the potential commercialization of MOLBREEVI, statements related to IMPALA-2 data presented and our view that MOLBREEVI could fundamentally change the way this rare and chronic lung disease is treated, and our goal to bring the first and only pharmacologic treatment for autoimmune PAP to market. Savara may not actually achieve any of the matters referred to in such forward-looking statements, and you should not place undue reliance on these forward-looking statements. These forward-looking statements are based upon Savara’s current expectations and involve assumptions that may never materialize or may prove to be incorrect. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties, which include, without limitation, the risks associated with our ability to successfully develop, obtain regulatory approval for, and commercialize MOLBREEVI for autoimmune PAP; the risks and uncertainties related to the impact of widespread health concerns or changing economic or geopolitical conditions; the ability to project future cash utilization and reserves needed for contingent future liabilities and business operations; the availability of sufficient resources for Savara’s operations and to conduct or continue planned clinical development programs; and the timing and ability of Savara to raise additional capital as needed to fund continued operations. All forward-looking statements are expressly qualified in their entirety by these cautionary statements. For a detailed description of our risks and uncertainties, you are encouraged to review our documents filed with the SEC including our recent filings on Form 8-K, Form 10-K and Form 10-Q. You are cautioned not to place undue reliance on forward-looking statements, which speak only as of the date on which they were made. Savara undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as may be required by law. Financial Information to Follow View source version on businesswire.com: https://www.businesswire.com/news/home/20251112721405/en/ Contacts Media and Investor Relations Contact Savara Inc. Temre Johnson, Executive Director, Corporate Affairs [email protected]
Investor releaseQuarter not tagged2025-10-03Savara Announces Encore Presentations of Results From the Phase 3 IMPALA-2 Clinical Trial of Molgramostim Inhalation Solution (Molgramostim) in Patients with Autoimmune Pulmonary Alveolar Proteinosis (aPAP) at CHEST 2025
Business Wire
Savara Announces Encore Presentations of Results From the Phase 3 IMPALA-2 Clinical Trial of Molgramostim Inhalation Solution (Molgramostim) in Patients with Autoimmune Pulmonary Alveolar Proteinosis (aPAP) at CHEST 2025
-- Savara’s Partner, TrilliumBiO, to Present Encore Data on the Development of a Dried Blood Spot Test to Aid in the Diagnosis of aPAP -- LANGHORNE, Pa., October 02, 2025--(BUSINESS WIRE)--Savara Inc. (Nasdaq: SVRA) (the Company), a clinical-stage biopharmaceutical company focused on rare respiratory diseases, today announced the acceptance of two abstracts for poster presentation and one abstract as an oral presentation at CHEST 2025 in Chicago, Illinois, October 19-22. The Company will also host a Learning Theatre titled "Advances in Autoimmune Pulmonary Alveolar Proteinosis" at the meeting which is open to all registered conference attendees. CHEST 2025 Posters, Oral Session and Learning Theater Savara Presentations Oral Presentation Title: Efficacy of Inhaled Molgramostim According to Severity of Autoimmune Pulmonary Alveolar Proteinosis (aPAP) Session Title: Innovations in Assessment and Treatment of Fibrosing Lung Disease Session ID: 4053 Date/Time of Presentation Session: October 21, 2025, 10:56-11:00 AM CDT Location: Exhibit Hall Rapid Fire 3A, McCormick Place, Chicago Presenter: Cormac McCarthy, M.D., Ph.D., FRCPI, Associate Professor of Medicine at the University College Dublin (UCD) and Consultant Respiratory Physician at St. Vincent’s University Hospital, Dublin, Ireland Poster Title: Relationship Between Pulmonary Gas Transfer, Respiratory Health-Related Quality of Life (HRQoL), Exercise Capacity, and Surfactant Burden in Autoimmune Pulmonary Alveolar Proteinosis (aPAP) Session Title: Diffuse Lung Disease Scientific Abstract Posters (D) Date/Time of Poster Discussion Session: October 22, 2025, 10:20-11:05 AM CDT Poster Number: 4260 Location: Poster Hall Exhibit, McCormick Place, Chicago Presenter: Bruce Trapnell, M.D., Professor of Medicine and Pediatrics at the University of Cincinnati College of Medicine TrilliumBiO Presentation Poster Title: Development of a Dried Serum Assay for the Detection of GM-CSF Antibodies to Aid in the Diagnosis of Autoimmune Pulmonary Alveolar Proteinosis (aPAP) Session Title: Diffuse Lung Disease Scientific Abstract Posters (D) Poster Number: 4257 Date/Time of Poster Presentation Session: October 22, 2025, 10:20-11:05 AM CDT Location: Poster Hall Exhibit, McCormick Place, Chicago Presenter: Eagappanath Thiruppathi, Ph.D., Director, Test and Method Development, TrilliumBiO Savara Learning Theater Title: Advances in…Read full documentShow less
-- Savara’s Partner, TrilliumBiO, to Present Encore Data on the Development of a Dried Blood Spot Test to Aid in the Diagnosis of aPAP -- LANGHORNE, Pa., October 02, 2025--(BUSINESS WIRE)--Savara Inc. (Nasdaq: SVRA) (the Company), a clinical-stage biopharmaceutical company focused on rare respiratory diseases, today announced the acceptance of two abstracts for poster presentation and one abstract as an oral presentation at CHEST 2025 in Chicago, Illinois, October 19-22. The Company will also host a Learning Theatre titled "Advances in Autoimmune Pulmonary Alveolar Proteinosis" at the meeting which is open to all registered conference attendees. CHEST 2025 Posters, Oral Session and Learning Theater Savara Presentations Oral Presentation Title: Efficacy of Inhaled Molgramostim According to Severity of Autoimmune Pulmonary Alveolar Proteinosis (aPAP) Session Title: Innovations in Assessment and Treatment of Fibrosing Lung Disease Session ID: 4053 Date/Time of Presentation Session: October 21, 2025, 10:56-11:00 AM CDT Location: Exhibit Hall Rapid Fire 3A, McCormick Place, Chicago Presenter: Cormac McCarthy, M.D., Ph.D., FRCPI, Associate Professor of Medicine at the University College Dublin (UCD) and Consultant Respiratory Physician at St. Vincent’s University Hospital, Dublin, Ireland Poster Title: Relationship Between Pulmonary Gas Transfer, Respiratory Health-Related Quality of Life (HRQoL), Exercise Capacity, and Surfactant Burden in Autoimmune Pulmonary Alveolar Proteinosis (aPAP) Session Title: Diffuse Lung Disease Scientific Abstract Posters (D) Date/Time of Poster Discussion Session: October 22, 2025, 10:20-11:05 AM CDT Poster Number: 4260 Location: Poster Hall Exhibit, McCormick Place, Chicago Presenter: Bruce Trapnell, M.D., Professor of Medicine and Pediatrics at the University of Cincinnati College of Medicine TrilliumBiO Presentation Poster Title: Development of a Dried Serum Assay for the Detection of GM-CSF Antibodies to Aid in the Diagnosis of Autoimmune Pulmonary Alveolar Proteinosis (aPAP) Session Title: Diffuse Lung Disease Scientific Abstract Posters (D) Poster Number: 4257 Date/Time of Poster Presentation Session: October 22, 2025, 10:20-11:05 AM CDT Location: Poster Hall Exhibit, McCormick Place, Chicago Presenter: Eagappanath Thiruppathi, Ph.D., Director, Test and Method Development, TrilliumBiO Savara Learning Theater Title: Advances in Autoimmune Pulmonary Alveolar Proteinosis Description: Kevin Davidson, M.D., FCCP, will provide an update on autoimmune pulmonary alveolar proteinosis, including the pathophysiology of this rare lung disease, signs and symptoms, diagnosis and management, and burden of illness. Date/Time: October 21, 12:30-1:15 pm CDT Location: Learning Theatre 1, McCormick Place, Chicago Presenter: Kevin Davidson, M.D., FCCP, Director of Interventional Pulmonology and Critical Care Medicine, WakeMed Hospitals, Raleigh, NC, USA Following the sessions, the posters and presentation slides will be available on the Congresses & Publications page of the Company’s corporate website. About the IMPALA-2 Trial IMPALA-2 is a global, pivotal, Phase 3, 48-week, randomized, double-blind, placebo-controlled clinical trial designed to compare the efficacy and safety of molgramostim 300 mcg self-administered once daily by inhalation with matching placebo in patients with aPAP. The trial is being conducted at 43 clinical trial sites across 16 countries, including the U.S., Canada, Japan, South Korea, Australia, and countries in Europe, including Turkey. The primary efficacy assessment was diffusing capacity of the lungs for carbon monoxide (DLco%), a gas transfer measure, and the primary endpoint was change from baseline to Week 24 in percent predicted DLco%, with a secondary endpoint of change from baseline to Week 48 in percent predicted DLco%. Three additional secondary efficacy variables evaluated clinical measures of direct patient benefit: St. George’s Respiratory Questionnaire (SGRQ) Total score, SGRQ Activity score, and exercise capacity using a treadmill test, with each endpoint measured at Weeks 24 and 48. The primary time point for efficacy assessments was at Week 24; however, efficacy was assessed through Week 48 to evaluate durability of effect. Safety was assessed through Week 48. All patients who completed the 48-week double-blind treatment period continued into a 96-week open-label period during which molgramostim 300 mcg is administered once daily. About Autoimmune Pulmonary Alveolar Proteinosis (aPAP) Autoimmune PAP is a rare lung disease characterized by the abnormal build-up of surfactant in the alveoli of the lungs. Surfactant consists of proteins and lipids and is an important physiological substance that lines the alveoli to prevent them from collapsing. In a healthy lung, excess surfactant is cleared and digested by immune cells called alveolar macrophages. Alveolar macrophages need to be stimulated by granulocyte-macrophage colony-stimulating factor (GM-CSF) to function properly in clearing surfactant, but in aPAP, GM-CSF is neutralized by antibodies against GM-CSF, rendering macrophages unable to adequately clear surfactant. As a result, an excess of surfactant accumulates in the alveoli, causing impaired gas transfer, resulting in clinical symptoms of shortness of breath, often with cough and frequent fatigue. Patients may also experience episodes of fever, chest pain, or coughing up blood, especially if secondary infection develops. In the long term, the disease can lead to serious complications, including lung fibrosis and the need for a lung transplant. About Savara Savara is a clinical-stage biopharmaceutical company focused on rare respiratory diseases. Our lead program, molgramostim inhalation solution (molgramostim), is a recombinant human granulocyte-macrophage colony-stimulating factor (GM-CSF) in Phase 3 development for autoimmune pulmonary alveolar proteinosis (aPAP). Molgramostim is delivered via a proprietary investigational eFlow® Nebulizer System (PARI Pharma GmbH) specifically developed for inhalation of molgramostim. Our management team has significant experience in rare respiratory diseases and pulmonary medicine, identifying unmet needs, and effectively advancing product candidates to approval and commercialization. More information can be found at www.savarapharma.com and LinkedIn. View source version on businesswire.com: https://www.businesswire.com/news/home/20251002013164/en/ Contacts Media and Investor Relations Contact Savara Inc. Temre Johnson, Executive Director, Corporate Affairs [email protected]
Investor releaseQuarter not tagged2025-08-21New England Journal of Medicine (NEJM) to Publish Results From Savara’s Pivotal Phase 3 IMPALA-2 Clinical Trial in Autoimmune Pulmonary Alveolar Proteinosis (Autoimmune PAP)
Business Wire
New England Journal of Medicine (NEJM) to Publish Results From Savara’s Pivotal Phase 3 IMPALA-2 Clinical Trial in Autoimmune Pulmonary Alveolar Proteinosis (Autoimmune PAP)
-- In the Largest Clinical Trial Conducted in Autoimmune PAP, Molgramostim Inhalation Solution (Molgramostim) Reduced Surfactant Burden and Improved Pulmonary Gas Transfer, Respiratory Health-Related Quality of Life, and Patient Functionality -- LANGHORNE, Pa., August 20, 2025--(BUSINESS WIRE)--Savara Inc. (Nasdaq: SVRA) (the Company), a clinical stage biopharmaceutical company focused on rare respiratory diseases, announced that the results from the Phase 3 IMPALA-2 clinical trial will be published online in NEJM. The manuscript, titled "A Phase 3 Trial of Inhaled Molgramostim Therapy in Autoimmune Pulmonary Alveolar Proteinosis" will appear in the August 21, 2025, online version of the publication and can be found at www.nejm.org. Following the online publication in NEJM, the manuscript will be available on the Congresses & Publications page of the Company’s corporate website. "IMPALA-2, the largest and longest Phase 3 clinical trial conducted in patients with autoimmune PAP, demonstrated that 48 weeks of once daily administration of inhaled molgramostim addresses the underlying pathophysiology of this chronic rare lung disease," said Bruce Trapnell, M.D., Professor of Medicine and Pediatrics, University of Cincinnati College of Medicine and Lead Clinical Investigator of the IMPALA-2 trial. "Treatment with molgramostim improved the cardinal manifestations of autoimmune PAP, namely it reduced pulmonary surfactant burden and improved pulmonary gas transfer, respiratory health-related quality of life, and patient functionality. Additionally, molgramostim was well tolerated with no notable safety concerns." IMPALA-2 achieved statistical significance on its primary endpoint, change from baseline in the hemoglobin-adjusted percent predicted diffusing capacity of the lungs for carbon monoxide (DLco%) at Week 24. Molgramostim significantly improved pulmonary gas transfer as measured by DLco% at Week 24 compared with placebo (9.8% vs. 3.8%; estimated treatment difference, 6.0%; P<0.001 by comparison of least-squares means [LSMs]). The beneficial effect of molgramostim on pulmonary gas transfer was maintained to Week 48 as shown by the difference in LSM change from baseline in DLco% at Week 48 between molgramostim and placebo groups (11.6% vs. 4.7%; estimated treatment difference, 6.9%; P<0.001). The mean improvements in DLco% from baseline for molgramostim (9.8% at…Read full documentShow less
-- In the Largest Clinical Trial Conducted in Autoimmune PAP, Molgramostim Inhalation Solution (Molgramostim) Reduced Surfactant Burden and Improved Pulmonary Gas Transfer, Respiratory Health-Related Quality of Life, and Patient Functionality -- LANGHORNE, Pa., August 20, 2025--(BUSINESS WIRE)--Savara Inc. (Nasdaq: SVRA) (the Company), a clinical stage biopharmaceutical company focused on rare respiratory diseases, announced that the results from the Phase 3 IMPALA-2 clinical trial will be published online in NEJM. The manuscript, titled "A Phase 3 Trial of Inhaled Molgramostim Therapy in Autoimmune Pulmonary Alveolar Proteinosis" will appear in the August 21, 2025, online version of the publication and can be found at www.nejm.org. Following the online publication in NEJM, the manuscript will be available on the Congresses & Publications page of the Company’s corporate website. "IMPALA-2, the largest and longest Phase 3 clinical trial conducted in patients with autoimmune PAP, demonstrated that 48 weeks of once daily administration of inhaled molgramostim addresses the underlying pathophysiology of this chronic rare lung disease," said Bruce Trapnell, M.D., Professor of Medicine and Pediatrics, University of Cincinnati College of Medicine and Lead Clinical Investigator of the IMPALA-2 trial. "Treatment with molgramostim improved the cardinal manifestations of autoimmune PAP, namely it reduced pulmonary surfactant burden and improved pulmonary gas transfer, respiratory health-related quality of life, and patient functionality. Additionally, molgramostim was well tolerated with no notable safety concerns." IMPALA-2 achieved statistical significance on its primary endpoint, change from baseline in the hemoglobin-adjusted percent predicted diffusing capacity of the lungs for carbon monoxide (DLco%) at Week 24. Molgramostim significantly improved pulmonary gas transfer as measured by DLco% at Week 24 compared with placebo (9.8% vs. 3.8%; estimated treatment difference, 6.0%; P<0.001 by comparison of least-squares means [LSMs]). The beneficial effect of molgramostim on pulmonary gas transfer was maintained to Week 48 as shown by the difference in LSM change from baseline in DLco% at Week 48 between molgramostim and placebo groups (11.6% vs. 4.7%; estimated treatment difference, 6.9%; P<0.001). The mean improvements in DLco% from baseline for molgramostim (9.8% at Week 24 and 11.6% at Week 48) are similar to the minimal clinically meaningful difference (MCID) in DLco% of 10% reported for pulmonary fibrosis.1 Molgramostim improved respiratory health-related quality of life as measured by the St. George’s Respiratory Questionnaire (SGRQ) Total and Activity scores. The magnitude of LSM reduction from baseline in SGRQ Total score was significantly greater in the molgramostim group than placebo at Week 24 (-11.5 points vs. -4.9 points, estimated difference, -6.6 points; P=0.007) and remained numerically greater at Week 48 (-10.7 points vs. -5.9 points, estimated difference, -4.9 points [95% confidence interval, -10.8, 1.0]). The LSM change from baseline in SGRQ Activity score was greater for molgramostim compared with placebo at Week 24 (-13.0 points vs. -5.2 points, estimated difference, -7.8 points [95% confidence interval, -14.1, -1.5]) and at Week 48 (-13.4 vs. -7.4 points, estimated difference, -6.0 points [95% confidence interval, -13.6, 1.6]). Molgramostim improved patient function as measured by exercise capacity (expressed as peak metabolic equivalents [METs]). A MET is a unit of resting oxygen uptake which measures energy expenditure. The LSM change from baseline in peak-METs was greater at Week 48 for molgramostim than placebo (1.1 vs. 0.6; estimated treatment difference, 0.6; [95% confidence interval, 0.1, 1.0]). Peak-METs is a clinically useful unit of measure reflecting exercise capacity, prognosis, and mortality in cardiovascular disease for which a 0.5-MET increase comprises a clinically useful measure of rehabilitation.2 Using the treadmill test in IMPALA-2, the LSM change in peak-METs from baseline to Week 48 was 1.1 in molgramostim-treated patients and the between-group difference observed at Week 48 was 0.6 peak-METs. Molgramostim reduced surfactant burden as measured by ground glass opacity (GGO) score, an exploratory endpoint in IMPALA-2; GGO scores were determined by two blinded radiologists from a chest CT scan, with scores ranging from 0 to 15 (higher scores are worse). The mean reduction from baseline in GGO score was greater in the molgramostim group than the placebo group at Week 24 (-2.1 vs -1.1). Further, the number of patients who received ≥1 whole lung lavage as rescue therapy during the double-blind intervention period was lower with molgramostim than placebo (6 [7%] vs. 11 [13%]). In IMPALA-2, molgramostim was well tolerated. Most treatment-emergent adverse events (AEs) were mild or moderate, and few led to discontinuation, with 98% of patients in the molgramostim group and 96% of patients in the placebo group completing the 48-week double-blind period on treatment. About IMPALA-2 IMPALA-2 was a global, pivotal, Phase 3, 48-week, randomized, double-blind, placebo-controlled clinical trial designed to compare the efficacy and safety of molgramostim 300 mcg self-administered once daily by inhalation with matching placebo in patients with autoimmune PAP. The trial was conducted at 43 clinical trial sites across 16 countries, including the U.S., Canada, Japan, South Korea, Australia, and countries in Europe, including Turkey. The primary efficacy assessment was hemoglobin-adjusted percent predicted diffusing capacity of the lungs for carbon monoxide (DLco%), a gas transfer measure, and the primary endpoint was change from baseline to Week 24 in percent predicted DLco%, with a secondary endpoint of change from baseline to Week 48 in percent predicted DLco%. Three additional secondary efficacy variables evaluated clinical measures of patient benefit: St. George’s Respiratory Questionnaire (SGRQ) Total score, SGRQ Activity score, and exercise capacity using a treadmill test, with each endpoint measured at Weeks 24 and 48. The primary time point for efficacy assessments was at Week 24; however, efficacy was assessed through Week 48 to evaluate durability of effect. Safety was assessed through Week 48. All patients who completed the 48-week double-blind treatment period continued into a 96-week open-label period during which molgramostim 300 mcg is administered once daily. About Autoimmune Pulmonary Alveolar Proteinosis (Autoimmune PAP) Autoimmune PAP is a rare lung disease characterized by the abnormal build-up of surfactant in the alveoli of the lungs. Surfactant consists of proteins and lipids and is an important physiological substance that lines the alveoli to prevent them from collapsing. In a healthy lung, excess surfactant is cleared and digested by immune cells called alveolar macrophages. Alveolar macrophages need to be stimulated by granulocyte-macrophage colony-stimulating factor (GM-CSF) to function properly in clearing surfactant, but in autoimmune PAP, GM-CSF is neutralized by antibodies against GM-CSF, rendering macrophages unable to adequately clear surfactant. As a result, an excess of surfactant accumulates in the alveoli, causing impaired gas transfer, resulting in clinical symptoms of shortness of breath, often with cough and frequent fatigue. Patients may also experience episodes of fever, chest pain, or coughing up blood, especially if secondary infection develops. In the long term, the disease can lead to serious complications, including lung fibrosis and the need for a lung transplant. About Savara Savara is a clinical stage biopharmaceutical company focused on rare respiratory diseases. Our lead program, molgramostim inhalation solution (molgramostim), is a recombinant human granulocyte-macrophage colony-stimulating factor (GM-CSF) in Phase 3 development for autoimmune pulmonary alveolar proteinosis (autoimmune PAP). Molgramostim is delivered via an investigational eFlow® Nebulizer System (PARI Pharma GmbH) specifically developed for inhalation of a large molecule. Our management team has significant experience in rare respiratory diseases and pulmonary medicine, identifying unmet needs, and effectively advancing product candidates to approval and commercialization. More information can be found at www.savarapharma.com and LinkedIn. 1 Raghu G, et al. Am J Respir Crit Care Med 2022;205:e18-e47. 2 Ross R, et al. Circulation 2016;134:e653-e99; Grace SL, et al. Can J Cardiol 2014;30:945-8; Kehler DS, et al. J Cardiopulm Rehabil Prev 2017;37:250-6. View source version on businesswire.com: https://www.businesswire.com/news/home/20250820194710/en/ Contacts Media and Investor Relations Contact Savara Inc. Temre Johnson, Executive Director, Corporate Affairs [email protected]
Investor releaseQuarter not tagged2025-08-13Savara Reports Second Quarter 2025 Financial Results and Provides a Business Update
Business Wire
Savara Reports Second Quarter 2025 Financial Results and Provides a Business Update
-- Reached Alignment with the U.S. Food and Drug Administration (FDA) on Information Needed for Resubmission of the Biologics License Application (BLA) for MOLBREEVI* as a Treatment for Autoimmune Pulmonary Alveolar Proteinosis (Autoimmune PAP) -- -- Plan to Resubmit the BLA in December with FUJIFILM Biotechnologies (Fujifilm) as the Drug Substance Manufacturer and Will Request Priority Review -- -- Anticipate Submitting the MOLBREEVI Marketing Authorization Applications for Autoimmune PAP to the European Medicines Agency (EMA) and the UK Medicines and Healthcare Products Regulatory Agency (MHRA) in 1Q 2026 -- -- Reported ~$146M in Cash and Short-Term Investments as of June 30, 2025, Company Believes It Is Sufficiently Capitalized into 1Q 2027 -- LANGHORNE, Pa., August 13, 2025--(BUSINESS WIRE)--Savara Inc. (Nasdaq: SVRA) (the Company), a clinical stage biopharmaceutical company focused on rare respiratory diseases, reported financial results for the second quarter ending June 30, 2025 and provided a business update. "Following a recent Type A meeting with the FDA, and receipt of the meeting minutes, we believe we have aligned on a path forward for the information needed to resubmit the BLA with Fujifilm as our drug substance manufacturer," said Matt Pauls, Chair and CEO, Savara. "With the Process Performance Qualification campaigns now complete at Fujifilm, and finalization of the analytical data package expected early in the fourth quarter, we plan to resubmit the BLA in December. We are grateful for the constructive and timely dialogue with the FDA and are pleased to be working with Fujifilm, a top 10 biologics manufacturer with more than 20 approved drug substances globally and a successful inspection history with numerous regulatory authorities." Pauls continued, "With no approved therapies in the United States or Europe for autoimmune PAP, there is a high unmet medical need to treat this rare and debilitating lung disease. We are committed to our goal of providing these patients with the first and only pharmacologic treatment option. We continue our work, with urgency, to pursue approval for MOLBREEVI." Second Quarter Financial Results (Unaudited) Savara's net loss for the second quarter of 2025 was $30.4 million, or $(0.14) per share, compared with a net loss of $22.2 million, or $(0.12) per share, for the second quarter of 2024. Research and developm…Read full documentShow less
-- Reached Alignment with the U.S. Food and Drug Administration (FDA) on Information Needed for Resubmission of the Biologics License Application (BLA) for MOLBREEVI* as a Treatment for Autoimmune Pulmonary Alveolar Proteinosis (Autoimmune PAP) -- -- Plan to Resubmit the BLA in December with FUJIFILM Biotechnologies (Fujifilm) as the Drug Substance Manufacturer and Will Request Priority Review -- -- Anticipate Submitting the MOLBREEVI Marketing Authorization Applications for Autoimmune PAP to the European Medicines Agency (EMA) and the UK Medicines and Healthcare Products Regulatory Agency (MHRA) in 1Q 2026 -- -- Reported ~$146M in Cash and Short-Term Investments as of June 30, 2025, Company Believes It Is Sufficiently Capitalized into 1Q 2027 -- LANGHORNE, Pa., August 13, 2025--(BUSINESS WIRE)--Savara Inc. (Nasdaq: SVRA) (the Company), a clinical stage biopharmaceutical company focused on rare respiratory diseases, reported financial results for the second quarter ending June 30, 2025 and provided a business update. "Following a recent Type A meeting with the FDA, and receipt of the meeting minutes, we believe we have aligned on a path forward for the information needed to resubmit the BLA with Fujifilm as our drug substance manufacturer," said Matt Pauls, Chair and CEO, Savara. "With the Process Performance Qualification campaigns now complete at Fujifilm, and finalization of the analytical data package expected early in the fourth quarter, we plan to resubmit the BLA in December. We are grateful for the constructive and timely dialogue with the FDA and are pleased to be working with Fujifilm, a top 10 biologics manufacturer with more than 20 approved drug substances globally and a successful inspection history with numerous regulatory authorities." Pauls continued, "With no approved therapies in the United States or Europe for autoimmune PAP, there is a high unmet medical need to treat this rare and debilitating lung disease. We are committed to our goal of providing these patients with the first and only pharmacologic treatment option. We continue our work, with urgency, to pursue approval for MOLBREEVI." Second Quarter Financial Results (Unaudited) Savara's net loss for the second quarter of 2025 was $30.4 million, or $(0.14) per share, compared with a net loss of $22.2 million, or $(0.12) per share, for the second quarter of 2024. 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 was primarily due to the performance of tasks related to our MOLBREEVI program, which included 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 and $1.1 million of costs related to Regulatory Affairs and Quality Assurance, partially offset by $1.3 million of reduced clinical costs. 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 was 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. As of June 30, 2025, the Company had cash, cash equivalents and short-term investments of ~$146.4 million and debt of ~$29.7 million. About Autoimmune Pulmonary Alveolar Proteinosis (Autoimmune PAP) Autoimmune PAP is a rare lung disease characterized by the abnormal build-up of surfactant in the alveoli of the lungs. Surfactant consists of proteins and lipids and is an important physiological substance that lines the alveoli to prevent them from collapsing. In a healthy lung, excess surfactant is cleared and digested by immune cells called alveolar macrophages. Alveolar macrophages need to be stimulated by granulocyte-macrophage colony-stimulating factor (GM-CSF) to function properly in clearing surfactant, but in autoimmune PAP, GM-CSF is neutralized by antibodies against GM-CSF, rendering macrophages unable to adequately clear surfactant. As a result, an excess of surfactant accumulates in the alveoli, causing impaired gas exchange, resulting in clinical symptoms of shortness of breath, often with cough and frequent fatigue. Patients may also experience episodes of fever, chest pain, or coughing up blood, especially if secondary lung infection develops. In the long term, the disease can lead to serious complications, including lung fibrosis and the need for a lung transplant. About Savara Savara is a clinical stage biopharmaceutical company focused on rare respiratory diseases. Our lead program, MOLBREEVI*, is a recombinant human granulocyte-macrophage colony-stimulating factor (GM-CSF) in Phase 3 development for autoimmune pulmonary alveolar proteinosis (autoimmune PAP). MOLBREEVI is delivered via an investigational eFlow® Nebulizer System (PARI Pharma GmbH) specifically developed for inhalation of a large molecule. Our management team has significant experience in rare respiratory diseases and pulmonary medicine, identifying unmet needs, and effectively advancing product candidates to approval and commercialization. More information can be found at www.savarapharma.com and LinkedIn. *MOLBREEVI is the FDA and EMA conditionally accepted trade name for molgramostim inhalation solution. It is not approved in any indication. MOLBREEVI is a trademark of Savara Inc. Forward-Looking Statements Savara cautions you that statements in this press release that are not a description of historical fact are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements may be identified by the use of words referencing future events or circumstances such as "expect," "intend," "plan," "anticipate," "believe," and "will," among others. Such statements include, but are not limited to, statements related to reaching alignment with the FDA on the information needed to resubmit the BLA with Fujifilm as the drug substance manufacturer, the expected timing for resubmission of the BLA and requesting priority review, the anticipated timing of the MAA submissions to the EMA and MHRA, our belief regarding the capitalization and cash runway of the Company, the expected timing of the finalization of the analytical data package, our goal of providing patients with the first and only pharmacologic treatment option for autoimmune PAP, and that we continue our work, with urgency, to pursue approval for MOLBREEVI. Savara may not actually achieve any of the matters referred to in such forward-looking statements, and you should not place undue reliance on these forward-looking statements. These forward-looking statements are based upon Savara’s current expectations and involve assumptions that may never materialize or may prove to be incorrect. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties, which include, without limitation, the risks associated with our ability to successfully develop, obtain regulatory approval for, and commercialize MOLBREEVI for autoimmune PAP; the risks and uncertainties related to the impact of widespread health concerns or changing economic or geopolitical conditions; the ability to project future cash utilization and reserves needed for contingent future liabilities and business operations; the availability of sufficient resources for Savara’s operations and to conduct or continue planned clinical development programs; and the timing and ability of Savara to raise additional capital as needed to fund continued operations. All forward-looking statements are expressly qualified in their entirety by these cautionary statements. For a detailed description of our risks and uncertainties, you are encouraged to review our documents filed with the SEC including our recent filings on Form 8-K, Form 10-K and Form 10-Q. You are cautioned not to place undue reliance on forward-looking statements, which speak only as of the date on which they were made. Savara undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as may be required by law. Financial Information to Follow View source version on businesswire.com: https://www.businesswire.com/news/home/20250813707584/en/ Contacts Media and Investor Relations Contact Savara Inc. Temre Johnson, Executive Director, Corporate Affairs [email protected]
Investor releaseQuarter not tagged2025-05-14Savara Reports First Quarter 2025 Financial Results and Provides a Business Update
Business Wire
Savara Reports First Quarter 2025 Financial Results and Provides a Business Update
-- Completed Submission of the Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for MOLBREEVI* as a Treatment for Autoimmune Pulmonary Alveolar Proteinosis (Autoimmune PAP) and Requested Priority Review -- -- Company Remains on Track to Submit the MOLBREEVI Marketing Authorization Application (MAA) for Autoimmune PAP to the European Medicines Agency (EMA) and the Medicines and Healthcare Products Regulatory Agency (MHRA) by End of the Year -- -- Entered into a Non-Dilutive Debt Financing in March for up to $200M Which Included $30M at Close to Refinance Existing Debt Facility -- -- Reported ~$172.5M in Cash and Short-Term Investments as of March 31, 2025, Company Believes it is Sufficiently Capitalized into 2H 2027 -- LANGHORNE, Pa., May 13, 2025--(BUSINESS WIRE)--Savara Inc. (Nasdaq: SVRA) (the Company), a clinical stage biopharmaceutical company focused on rare respiratory diseases, reported financial results for the first quarter ending March 31, 2025 and provided a business update. "At the end of 1Q 2025, we announced the on-time submission of the MOLBREEVI BLA to the FDA for the treatment of autoimmune PAP and requested priority review," said Matt Pauls, Chair and Chief Executive Officer, Savara. "If Priority Review is granted, we anticipate a PDUFA date by the end of the year and are preparing for a U.S. commercial launch in early 2026. We are also on track to submit the MAA in both Europe and the U.K. by the end of the year. Lastly, with approximately $172.5 million in cash, and the optionality to further finance the company through access to low-cost capital from our recent debt financing, we are in a strong financial position and believe our current cash runway extends into 2H 2027, well beyond a U.S. launch." Upcoming Presentations at American Thoracic Society (ATS) Conference New data from the Phase 3 IMPALA-2 trial of MOLBREEVI in patients with autoimmune PAP will be presented at the ATS International Conference 2025 in San Francisco, May 16-21, 2025. The Company is also hosting an Industry Symposium with leading key opinion leaders in autoimmune PAP. For more information see our recent press release. First Quarter Financial Results (Unaudited) Savara's net loss for the first quarter of 2025 was $26.6 million, or $(0.12) per share, compared with a net loss of $20.3 million, or $(0.11) per share, for the first qua…Read full documentShow less
-- Completed Submission of the Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for MOLBREEVI* as a Treatment for Autoimmune Pulmonary Alveolar Proteinosis (Autoimmune PAP) and Requested Priority Review -- -- Company Remains on Track to Submit the MOLBREEVI Marketing Authorization Application (MAA) for Autoimmune PAP to the European Medicines Agency (EMA) and the Medicines and Healthcare Products Regulatory Agency (MHRA) by End of the Year -- -- Entered into a Non-Dilutive Debt Financing in March for up to $200M Which Included $30M at Close to Refinance Existing Debt Facility -- -- Reported ~$172.5M in Cash and Short-Term Investments as of March 31, 2025, Company Believes it is Sufficiently Capitalized into 2H 2027 -- LANGHORNE, Pa., May 13, 2025--(BUSINESS WIRE)--Savara Inc. (Nasdaq: SVRA) (the Company), a clinical stage biopharmaceutical company focused on rare respiratory diseases, reported financial results for the first quarter ending March 31, 2025 and provided a business update. "At the end of 1Q 2025, we announced the on-time submission of the MOLBREEVI BLA to the FDA for the treatment of autoimmune PAP and requested priority review," said Matt Pauls, Chair and Chief Executive Officer, Savara. "If Priority Review is granted, we anticipate a PDUFA date by the end of the year and are preparing for a U.S. commercial launch in early 2026. We are also on track to submit the MAA in both Europe and the U.K. by the end of the year. Lastly, with approximately $172.5 million in cash, and the optionality to further finance the company through access to low-cost capital from our recent debt financing, we are in a strong financial position and believe our current cash runway extends into 2H 2027, well beyond a U.S. launch." Upcoming Presentations at American Thoracic Society (ATS) Conference New data from the Phase 3 IMPALA-2 trial of MOLBREEVI in patients with autoimmune PAP will be presented at the ATS International Conference 2025 in San Francisco, May 16-21, 2025. The Company is also hosting an Industry Symposium with leading key opinion leaders in autoimmune PAP. For more information see our recent press release. First Quarter Financial Results (Unaudited) Savara's net loss for the first quarter of 2025 was $26.6 million, or $(0.12) per share, compared with a net loss of $20.3 million, or $(0.11) per share, for the first quarter of 2024. Research and development expenses increased by $2.4 million, or 14.0%, to $19.2 million for the three months ended March 31, 2025 from $16.8 million for the three months ended March 31, 2024. This increase was primarily due to the performance of tasks related to our MOLBREEVI program with $2.3 million related to regulatory affairs and quality assurance, and $0.1 million in departmental overhead. General and administrative expenses increased by $3.6 million, or 64.1%, to $9.2 million for the three months ended March 31, 2025 from $5.6 million for the three months ended March 31, 2024. The increase was due to personnel and related costs of $2.4 million, certain commercial activities of $0.8 million, and other departmental overhead of $0.4 million. As of March 31, 2025, the Company had cash, cash equivalents and short-term investments of ~$172.5 million and debt of ~$29.5 million. About Autoimmune Pulmonary Alveolar Proteinosis (autoimmune PAP) Autoimmune PAP is a rare lung disease characterized by the abnormal build-up of surfactant in the alveoli of the lungs. Surfactant consists of proteins and lipids and is an important physiological substance that lines the alveoli to prevent them from collapsing. In a healthy lung, excess surfactant is cleared and digested by immune cells called alveolar macrophages. Alveolar macrophages need to be stimulated by granulocyte-macrophage colony-stimulating factor (GM-CSF) to function properly in clearing surfactant, but in autoimmune PAP, GM-CSF is neutralized by antibodies against GM-CSF, rendering macrophages unable to adequately clear surfactant. As a result, an excess of surfactant accumulates in the alveoli, causing impaired gas exchange, resulting in clinical symptoms of shortness of breath, often with cough and frequent fatigue. Patients may also experience episodes of fever, chest pain, or coughing up blood, especially if secondary lung infection develops. In the long term, the disease can lead to serious complications, including lung fibrosis and the need for a lung transplant. About Savara Savara is a clinical stage biopharmaceutical company focused on rare respiratory diseases. Our lead program, MOLBREEVI*, is a recombinant human granulocyte-macrophage colony-stimulating factor (GM-CSF) in Phase 3 development for autoimmune pulmonary alveolar proteinosis (autoimmune PAP). MOLBREEVI is delivered via an investigational eFlow® Nebulizer System (PARI Pharma GmbH) specifically developed for inhalation of a large molecule. Our management team has significant experience in rare respiratory diseases and pulmonary medicine, identifying unmet needs, and effectively advancing product candidates to approval and commercialization. More information can be found at www.savarapharma.com and LinkedIn. *MOLBREEVI is the FDA and EMA conditionally accepted trade name for molgramostim inhalation solution. It is not approved in any indication. MOLBREEVI is a trademark of Savara Inc. Forward-Looking Statements Savara cautions you that statements in this press release that are not a description of historical fact are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements may be identified by the use of words referencing future events or circumstances such as "expect," "intend," "plan," "anticipate," "believe," and "will," among others. Such statements include, but are not limited to, statements related to the timing of the MAA submissions to the EMA and MHRA, our belief regarding the capitalization and cash runway of the Company, including the impact of our recent debt financing, statements related to the impact of Priority Review and the anticipated timing for a PDUFA date and commercial launch of MOLBREEVI, and statements relating to the Company’s planned presentations and activities at the ATS International Conference 2025. Savara may not actually achieve any of the matters referred to in such forward-looking statements, and you should not place undue reliance on these forward-looking statements. These forward-looking statements are based upon Savara’s current expectations and involve assumptions that may never materialize or may prove to be incorrect. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties, which include, without limitation, the risks associated with our ability to successfully develop, obtain regulatory approval for, and commercialize MOLBREEVI for autoimmune PAP; the risks and uncertainties related to the impact of widespread health concerns or changing economic or geopolitical conditions; the ability to project future cash utilization and reserves needed for contingent future liabilities and business operations; the availability of sufficient resources for Savara’s operations and to conduct or continue planned clinical development programs; and the timing and ability of Savara to raise additional capital as needed to fund continued operations. All forward-looking statements are expressly qualified in their entirety by these cautionary statements. For a detailed description of our risks and uncertainties, you are encouraged to review our documents filed with the SEC including our recent filings on Form 8-K, Form 10-K and Form 10-Q. You are cautioned not to place undue reliance on forward-looking statements, which speak only as of the date on which they were made. Savara undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as may be required by law. Financial Information to Follow View source version on businesswire.com: https://www.businesswire.com/news/home/20250513334917/en/ Contacts Media and Investor Relations Contact Savara Inc. Temre Johnson, Executive Director, Corporate Affairs [email protected]
Investor releaseQuarter not tagged2025-03-27Savara Reports Fourth Quarter and Year End 2024 Financial Results and Provides Business Update
Business Wire
Savara Reports Fourth Quarter and Year End 2024 Financial Results and Provides Business Update
-- Completed Submission of the Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for MOLBREEVI* as a Treatment for Autoimmune Pulmonary Alveolar Proteinosis (aPAP) -- -- Priority Review Was Requested, Commercial Launch Preparations Underway -- -- With ~$196M in Cash and Short-Term Investments as of December 31, 2024, the Company Believes it is Sufficiently Capitalized through 2Q 2027, Excluding the Recent Debt Financing of Up To $200M -- LANGHORNE, Pa., March 27, 2025--(BUSINESS WIRE)--Savara Inc. (Nasdaq: SVRA) (the Company), a clinical stage biopharmaceutical company focused on rare respiratory diseases, reported financial results for the fourth quarter and full year ending December 31, 2024 and provided a business update. "Completing submission of the BLA is an important milestone in potentially addressing the significant unmet need of people living with aPAP, a rare and debilitating lung disease," said Matt Pauls, Chair and Chief Executive Officer, Savara. "MOLBREEVI has the potential to be the first and only approved therapy for aPAP in the U.S. and Europe and could redefine the standard of care for the disease. If granted Priority Review, we could have a PDUFA date by the end of the year and are preparing for a commercial launch in early 2026. Lastly, with approximately $196 million in cash, we are in a strong financial position and believe our cash runway extends through 2Q 2027, excluding our recent debt financing which adds additional low-cost capital options to further finance the Company." In addition to Fast Track and Breakthrough Therapy Designations, MOLBREEVI has been granted Orphan Drug Designation for the treatment of aPAP 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). Fourth Quarter Financial Results (Unaudited) Savara's net loss for the fourth quarter of 2024 was $29.0 million, or $(0.13) per share, compared with a net loss of $16.1 million, or $(0.09) per share, for the fourth quarter of 2023. Research and development expenses for the fourth quarter of 2024 and 2023 were $23.3 million and $12.7 million, respectively. General and administrative expenses for the fourth quarter of 2024 and 2023 were $7.8 million and $4.9 million, respectively. As…Read full documentShow less
-- Completed Submission of the Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for MOLBREEVI* as a Treatment for Autoimmune Pulmonary Alveolar Proteinosis (aPAP) -- -- Priority Review Was Requested, Commercial Launch Preparations Underway -- -- With ~$196M in Cash and Short-Term Investments as of December 31, 2024, the Company Believes it is Sufficiently Capitalized through 2Q 2027, Excluding the Recent Debt Financing of Up To $200M -- LANGHORNE, Pa., March 27, 2025--(BUSINESS WIRE)--Savara Inc. (Nasdaq: SVRA) (the Company), a clinical stage biopharmaceutical company focused on rare respiratory diseases, reported financial results for the fourth quarter and full year ending December 31, 2024 and provided a business update. "Completing submission of the BLA is an important milestone in potentially addressing the significant unmet need of people living with aPAP, a rare and debilitating lung disease," said Matt Pauls, Chair and Chief Executive Officer, Savara. "MOLBREEVI has the potential to be the first and only approved therapy for aPAP in the U.S. and Europe and could redefine the standard of care for the disease. If granted Priority Review, we could have a PDUFA date by the end of the year and are preparing for a commercial launch in early 2026. Lastly, with approximately $196 million in cash, we are in a strong financial position and believe our cash runway extends through 2Q 2027, excluding our recent debt financing which adds additional low-cost capital options to further finance the Company." In addition to Fast Track and Breakthrough Therapy Designations, MOLBREEVI has been granted Orphan Drug Designation for the treatment of aPAP 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). Fourth Quarter Financial Results (Unaudited) Savara's net loss for the fourth quarter of 2024 was $29.0 million, or $(0.13) per share, compared with a net loss of $16.1 million, or $(0.09) per share, for the fourth quarter of 2023. Research and development expenses for the fourth quarter of 2024 and 2023 were $23.3 million and $12.7 million, respectively. General and administrative expenses for the fourth quarter of 2024 and 2023 were $7.8 million and $4.9 million, respectively. As of December 31, 2024, the Company had cash, cash equivalents and short-term investments of $196.3 million. Fiscal Year 2024 Financial Results The Company’s net loss for the year ended December 31, 2024 was $95.9 million, or $(0.48) per share, compared with a net loss of $54.7 million, or $(0.33) per share for the year ended December 31, 2023. Research and development expenses increased $33.8 million, or 76.3%, to $78.0 million for the year ended December 31, 2024 from $44.3 million for the year ended December 31, 2023. This increase was primarily due to the performance of tasks related to our MOLBREEVI program which includes approximately $19.9 million 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 the IMPALA-2 trial, IMPACT trial in pediatric aPAP, and Savara Early Access Program, 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. General and administrative expenses increased $9.4 million, or 59.8%, to $25.0 million for the year ended December 31, 2024 from $15.7 million for the year ended December 31, 2023. The increase was 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. About Autoimmune Pulmonary Alveolar Proteinosis (aPAP) aPAP is a rare lung disease characterized by the abnormal build-up of surfactant in the alveoli of the lungs. Surfactant consists of proteins and lipids and is an important physiological substance that lines the alveoli to prevent them from collapsing. In a healthy lung, excess surfactant is cleared and digested by immune cells called alveolar macrophages. Alveolar macrophages need to be stimulated by granulocyte-macrophage colony-stimulating factor (GM-CSF) to function properly in clearing surfactant, but in aPAP, GM-CSF is neutralized by antibodies against GM-CSF, rendering macrophages unable to adequately clear surfactant. As a result, an excess of surfactant accumulates in the alveoli, causing impaired gas exchange, resulting in clinical symptoms of shortness of breath, often with cough and frequent fatigue. Patients may also experience episodes of fever, chest pain, or coughing up blood, especially if secondary lung infection develops. In the long-term, the disease can lead to serious complications, including lung fibrosis and the need for a lung transplant. About Savara Savara is a clinical stage biopharmaceutical company focused on rare respiratory diseases. Our lead program, MOLBREEVI*, is a recombinant human granulocyte-macrophage colony-stimulating factor (GM-CSF) in Phase 3 development for autoimmune pulmonary alveolar proteinosis (aPAP). MOLBREEVI is delivered via an investigational eFlow® Nebulizer System (PARI Pharma GmbH) specifically developed for inhalation of a large molecule. Our management team has significant experience in rare respiratory diseases and pulmonary medicine, identifying unmet needs, and effectively advancing product candidates to approval and commercialization. More information can be found at www.savarapharma.com and LinkedIn. *MOLBREEVI is the FDA and EMA conditionally accepted trade name for molgramostim inhalation solution. It is not approved in any indication. MOLBREEVI is a trademark of Savara Inc. Forward-Looking Statements Savara cautions you that statements in this press release that are not a description of historical fact are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements may be identified by the use of words referencing future events or circumstances such as "expect," "intend," "plan," "anticipate," "believe," and "will," among others. Such statements include, but are not limited to, our belief regarding the capitalization and cash runway of the Company, statements related to potentially addressing the significant unmet need of people living with aPAP, MOLBREEVI having the potential to be the first and only approved therapy for aPAP in the U.S. and Europe and could redefine the standard of care for the disease, and statements related to the impact of Priority Review and the anticipated timing for commercial launch of MOLBREEVI. Savara may not actually achieve any of the matters referred to in such forward-looking statements, and you should not place undue reliance on these forward-looking statements. These forward-looking statements are based upon Savara’s current expectations and involve assumptions that may never materialize or may prove to be incorrect. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties, which include, without limitation, the risks associated with our ability to successfully develop, obtain regulatory approval for, and commercialize MOLBREEVI for aPAP; the risks and uncertainties related to the impact of widespread health concerns or changing economic or geopolitical conditions; the ability to project future cash utilization and reserves needed for contingent future liabilities and business operations; the availability of sufficient resources for Savara’s operations and to conduct or continue planned clinical development programs; and the timing and ability of Savara to raise additional capital as needed to fund continued operations. All forward-looking statements are expressly qualified in their entirety by these cautionary statements. For a detailed description of our risks and uncertainties, you are encouraged to review our documents filed with the SEC including our recent filings on Form 8-K, Form 10-K and Form 10-Q. You are cautioned not to place undue reliance on forward-looking statements, which speak only as of the date on which they were made. Savara undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as may be required by law. Financial Information to Follow View source version on businesswire.com: https://www.businesswire.com/news/home/20250327745241/en/ Contacts Media and Investor Relations Contact Savara Inc. Temre Johnson, Executive Director, Corporate Affairs [email protected]

