Live nieuws • May 22
Savara Phase 3 Data Shows Molgramostim Boosts Exercise Capacity and Biomarkers in aPAP Patients Savara reported new Phase 3 IMPALA-2 data showing that molgramostim inhalation solution for autoimmune pulmonary alveolar proteinosis (aPAP) led to statistically significant gains in exercise distance and exercise duration at Week 48 versus placebo.
The trial also showed statistically significant improvements in pulmonary gas transfer for patients receiving molgramostim compared with placebo.
Molgramostim treatment was associated with reduced serum biomarker levels tied to disease severity, and these reductions correlated with better functional lung outcomes.
The alignment between clinical endpoints such as exercise capacity and biomarker changes points to a more complete picture of potential treatment benefit for aPAP.
For investors, the key question from here is how these data may support regulatory discussions, potential labeling, and ultimately physician adoption and payer coverage if molgramostim progresses toward commercialization. Aankondiging • May 20
Savara Inc Announces New Exercise Capacity Data From The IMPALA-2 Phase 3 Clinical Trial Of Molgramostim Inhalation Solution In Autoimmune Pulmonary Alveolar Proteinosis Savara Inc. sponsored an oral presentation at the ATS 2026 International Conference that is taking place May 15-20, 2026, in Orlando, Florida. The presentation reported new exercise capacity data from the double-blind period of the IMPALA-2 Phase 3 clinical trial evaluating molgramostim for the treatment of autoimmune pulmonary alveolar proteinosis. Presented exercise capacity data from IMPALA-2, a global, randomized, double-blind, placebo-controlled Phase 3 clinical trial in which adults with autoimmune pulmonary alveolar proteinosis received nebulized molgramostim 300 µg (n=81) or placebo (n=83) once daily for 48 weeks. IMPALA-2 achieved statistical significance on its primary endpoint and other secondary endpoints, including a greater mean improvement in exercise capacity, expressed as peak metabolic equivalents (METs), in the molgramostim group at 48 weeks. This oral presentation reported on the effects of molgramostim on exploratory endpoints of exercise distance and duration, assessed at Weeks 24 and 48 via a conservative, ramp-up, symptom-limited, exercise treadmill test. Greater mean improvement in distance walked was observed in molgramostim-treated patients compared with placebo at Week 48. The least-squares mean (LSM) change in distance walked from baseline to Week 48 was 167.0 m (95% confidence interval [CI], 112.1 to 221.8) in the molgramostim group and 86.4 m (95% CI, 32.4 to 140.4) in the placebo group, yielding an estimated treatment difference of 80.6 m (P=0.0301). Molgramostim patients were also able to exercise for longer periods of time compared with patients who received placebo. At Week 48, the LSM change in duration of exercise from baseline was 2.0 minutes (95% CI, 1.3 to 2.7) in the molgramostim group and 1.0 minute (95% CI, 0.3 to 1.6) in the placebo group, yielding an estimated treatment difference of 1.0 minute (P=0.0262). Consistent with improvements in peak METs, molgramostim improved both distance walked and duration of exercise at Week 48 compared with placebo, supporting the potential clinical benefit of molgramostim treatment in patients with autoimmune pulmonary alveolar proteinosis. The full content of this poster will be available on the Congresses and Publications page of the Savara corporate website. The abstract is published in a supplement of the American Journal of Respiratory and Critical Care Medicine. Major Estimate Revision • May 19
Consensus revenue estimates fall by 71% The consensus outlook for revenues in fiscal year 2026 has deteriorated. 2026 revenue forecast decreased from US$11.0m to US$3.18m. Forecast losses increased from -US$0.486 to -US$0.541 per share. Biotechs industry in the US expected to see average net income decline 8.9% next year. Consensus price target of US$10.81 unchanged from last update. Share price fell 4.1% to US$4.91 over the past week. Major Estimate Revision • Apr 19
Consensus revenue estimates fall by 11% The consensus outlook for revenues in fiscal year 2026 has deteriorated. 2026 revenue forecast decreased from US$16.5m to US$14.7m. Forecast losses increased from -US$0.466 to -US$0.472 per share. Biotechs industry in the US expected to see average net income decline 12% next year. Consensus price target down from US$10.81 to US$10.56. Share price rose 2.1% to US$5.78 over the past week. Aankondiging • Apr 16
Savara Announces the U.S. Food & Drug Administration Has Extended the Review Period for the Molgramostim Inhalation Solution (Molgramostim) Biologics License Application in Autoimmune Pulmonary Alveolar Proteinosis Savara Inc. announced that the FDA has extended the review period for the molgramostim BLA in autoimmune PAP by three months. The Agency is reviewing the molgramostim BLA under Priority Review and the new PDUFA target action date is November 22, 2026. The FDA determined that the Company’s responses to recent information requests by the Agency constituted a major amendment to the BLA, resulting in a three-month extension of the PDUFA date. The Agency did not cite any safety, efficacy, or manufacturing concerns in their correspondence. This extension allows the FDA additional time to complete their review of the BLA, including recently submitted materials related to information requests. 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. Aankondiging • Apr 13
Savara Inc., Annual General Meeting, Jun 04, 2026 Savara Inc., Annual General Meeting, Jun 04, 2026. Aankondiging • Apr 08
Savara Inc. Announces MHRA Accepts Molbreevi Marketing Authorisation Application for Autoimmune PAP Savara Inc. announced that the MHRA has accepted the submission of the MOLBREEVI MAA for the treatment of autoimmune PAP in the U.K. The MAA was accepted under Accelerated Review and qualifies for a 150-day assessment duration. A decision on the application is expected in Fourth Quarter 2026. In the U.S., the FDA is reviewing the MOLBREEVI BLA under Priority Review with an August 22, 2026 Prescription Drug User Fee Act (PDUFA) date. In Europe, the MOLBREEVI MAA is being reviewed by the Committee for Medicinal Products for Human Use (CHMP) with a decision expected in First Quarter 2027. In addition to Fast Track and Breakthrough Therapy Designations in the U.S., MOLBREEVI has been granted Orphan Drug Designation for the treatment of autoimmune PAP by the FDA and the EMA, as well as Innovation Passport and Promising Innovative Medicine designations by the MHRA. 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. 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. Aankondiging • Mar 30
Savara Inc. Announces Validation Of Marketing Authorization Application For Molbreevi In Autoimmune Pulmonary Alveolar Proteinosis Savara Inc. announced that the European Medicines Agency (EMA) has validated the submission of the MOLBREEVI Marketing Authorization Application (MAA) in autoimmune pulmonary alveolar proteinosis (autoimmune PAP); the submission will now be reviewed by the Committee for Medicinal Products for Human Use (CHMP). In the U.S., the Food and Drug Administration (FDA) is reviewing the MOLBREEVI Biologics License Application (BLA) under Priority Review with an August 22, 2026 Action Date. MOLBREEVI MAA was submitted to the U.K. Medicines and Healthcare Products Regulatory Agency (MHRA) in March 2026. MOLBREEVI has been granted Fast Track and Breakthrough Therapy Designations, Orphan Drug Designation for the treatment of autoimmune PAP by the FDA and the EMA, as well as Innovation Passport and Promising Innovative Medicine designations by the MHRA. 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. 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. Major Estimate Revision • Mar 20
Consensus EPS estimates fall by 14% The consensus outlook for fiscal year 2026 has been updated. 2026 expected loss increased from -US$0.41 to -US$0.467 per share. Revenue forecast of US$16.5m unchanged since last update. Biotechs industry in the US expected to see average net income decline 12% next year. Consensus price target of US$10.81 unchanged from last update. Share price fell 3.0% to US$5.16 over the past week. New Risk • Mar 16
New minor risk - Shareholder dilution The company's shareholders have been diluted in the past year. Increase in shares outstanding: 18% This is considered a minor risk. Shareholder dilution occurs when there is an increase in the number of shares on issue that is not proportionally distributed between all shareholders. Often due to the company raising equity capital or some options being converted into stock. All else being equal, if there are more shares outstanding then each existing share will be entitled to a lower proportion of the company's total earnings, thus reducing earnings per share (EPS). While dilution might not always result in lower EPS (like if the company is using the capital to fund an EPS accretive acquisition) in a lot cases it does, along with lower dividends per share and less voting power at shareholder meetings. Currently, the following risks have been identified for the company: Major Risk Revenue is less than US$1m. Minor Risk Shareholders have been diluted in the past year (18% increase in shares outstanding). Aankondiging • Mar 07
Savara Inc Provides Regulatory Update on the Molbreevi Development Program in Autoimmune Pulmonary Alveolar Proteinosis Savara Inc. had received the Day 74 Letter from the FDA which indicated that an Advisory Committee meeting is not planned for the MOLBREEVI Biologics License Application (BLA) and the review is ongoing with a Prescription Drug User Fee Act (PDUFA) target action date of August 22, 2026. Additionally, the Company recently submitted the Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for MOLBREEVI for the treatment of autoimmune PAP and is on track to submit the MAA to the U.K.’s Medicines and Healthcare Products Regulatory Agency (MHRA) by the end of First Quarter 2026. MOLBREEVI was granted Fast Track and Breakthrough Therapy Designations by the FDA, Orphan Drug Designation by the FDA and by the EMA, and Innovation Passport (IP) and Promising Innovative Medicine (PIM) designations by the UK’s MHRA for the treatment of 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 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. 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. 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. Aankondiging • Feb 21
Savara Inc. Announces U.S. Food and Drug Administration Filed the MOLBREEVI Biologics License Application (BLA) in Autoimmune Pulmonary Alveolar Proteinosis (Autoimmune PAP) Savara Inc. announced the FDA has filed for review the BLA for MOLBREEVI as a therapy to treat patients with autoimmune PAP. The FDA granted Priority Review with a PDUFA action date of August 22, 2026. FDA Priority Review designation directs overall attention and resources to the evaluation of applications for drugs that, if approved, would be significant improvements in the safety or effectiveness of the treatment, diagnosis, or prevention of serious conditions when compared to standard review applications. In addition to Fast Track and Breakthrough Therapy Designations, MOLBREEVI has been granted Orphan Drug Designations 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. Breakeven Date Change • Dec 31
Forecast to breakeven in 2028 The 7 analysts covering Savara expect the company to break even for the first time. New consensus forecast suggests the company will make a profit of US$28.8m in 2028. Average annual earnings growth of 58% is required to achieve expected profit on schedule. Aankondiging • Dec 24
Savara Inc. Resubmits the Biologics License Application (Bla) to the U.S. Food and Drug Administration for Molbreevi for the Potential Treatment of Autoimmune Pulmonary Alveolar Proteinosis Savara Inc. announced that it has resubmitted the MOLBREEVI BLA to the FDA, with Fujifilm as the drug substance manufacturer. The MOLBREEVI BL A submission is seeking approval for the treatment of autoimmune PAP, a chronic and debilitating rare lung disease characterized by the abnormal build-up of surfactant in the alveoli. The Company has requested Priority Review of the application. MOLBREEVI was granted Fast Track and Breakthrough Therapy Designations by the FDA, Orphan Drug Designation by the FDA and by the European Medicines Agency (EMA), and Innovation Passport (IP) and Promising Innovative Medicine (PIM) designations by the UK's Medicines and Healthcare Products Regulatory Agency (MHRA) for the treatment of autoimmune P AP. Aankondiging • Dec 11
Savara Inc. Announces European Patent Office Intends to Grant A Patent for the Liquid Formulation of MOLBREEVI Savara Inc. announced the EPO notified the Company of its intention to grant a patent application covering the liquid formulation of MOLBREEVI, an orally inhaled recombant human granulocyte-macrophage colony-stimulating factor (GM-CSF). MOLBREEVI, delivered via the proprietary eFlow®? Nebulizer System, has been granted Fast Track and Breakthrough Therapy Designations by the U.S. Food and Drug Administration (FDA), Orphan Drug Designation by the FDA and by the European Medicines Agency (EMA), and Innovation Passport (IP) and Promising Innovative Medicine (PIM) designations by the U.K.'s Medicines and Healthcare Products Regulatory Agency (MHRA) for the treatment of autoimmune PAP. Autoimmune PAP is a rare lung disease characterized by the abnormal build-up of surfactant in the alveoli of the lungs. New Risk • Nov 14
New minor risk - Shareholder dilution The company's shareholders have been diluted in the past year. Increase in shares outstanding: 15% This is considered a minor risk. Shareholder dilution occurs when there is an increase in the number of shares on issue that is not proportionally distributed between all shareholders. Often due to the company raising equity capital or some options being converted into stock. All else being equal, if there are more shares outstanding then each existing share will be entitled to a lower proportion of the company's total earnings, thus reducing earnings per share (EPS). While dilution might not always result in lower EPS (like if the company is using the capital to fund an EPS accretive acquisition) in a lot cases it does, along with lower dividends per share and less voting power at shareholder meetings. Currently, the following risks have been identified for the company: Major Risk Revenue is less than US$1m. Minor Risk Shareholders have been diluted in the past year (15% increase in shares outstanding). New Risk • Nov 05
New minor risk - Shareholder dilution The company's shareholders have been diluted in the past year. Increase in shares outstanding: 18% This is considered a minor risk. Shareholder dilution occurs when there is an increase in the number of shares on issue that is not proportionally distributed between all shareholders. Often due to the company raising equity capital or some options being converted into stock. All else being equal, if there are more shares outstanding then each existing share will be entitled to a lower proportion of the company's total earnings, thus reducing earnings per share (EPS). While dilution might not always result in lower EPS (like if the company is using the capital to fund an EPS accretive acquisition) in a lot cases it does, along with lower dividends per share and less voting power at shareholder meetings. Currently, the following risks have been identified for the company: Major Risk Revenue is less than US$1m. Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (US$3.1m net loss in 3 years). Shareholders have been diluted in the past year (18% increase in shares outstanding). Aankondiging • Oct 17
Savara Inc. Announces Executive Changes Savara Inc. announced Yasmine Wasfi, M.D., Ph.D., FCCP has been promoted to CMO, effective immediately. She succeeds Ray Pratt, M.D., FACP who will transition from his current role to Senior Medical Advisor. Dr. Wasfi will report directly to the Company’s Chair and Chief Executive Officer and will serve as a member of the executive leadership team. Previously, Dr. Wasfi was Executive Vice President, Head of Clinical Development and Clinical Operations at Savara. Dr. Wasfi is a seasoned professional within clinical research and drug development of both large and small molecule novel therapeutics. Her clinical development work includes respiratory drug development and late-phase immunology clinical development. Dr. Wasfi has held roles of increasing responsibility within large pharmaceutical and smaller biotech companies, including Amicus Therapeutics, Johnson & Johnson, and Merck. She received a B.A. in Biology from the University of Delaware, M.D. from the University of Pennsylvania School of Medicine, and Ph.D. in Clinical Science from the University of Colorado Health Sciences Center. She completed her internship and residency in internal medicine at the Hospital of the University of Pennsylvania, and her fellowship in Pulmonary and Critical Care at the University of Colorado Health Sciences Center. Aankondiging • Oct 03
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 Inc. 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. CHEST 2025 Posters and Learning Theater. CHEST 25 Posters, Oral Session and learning Theater. CHEST 2025 Poster: 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. Aankondiging • Sep 30
Savara Inc. Presents New Data from the Phase 3 IMPALA-2 Clinical Trial of Molgramostim Inhalation Solution (Molgramostim) in Patients with Autoimmune Pulmonary Alveolar Proteinosis at the European Respiratory Society (ERS) Congress 2025 Savara Inc. announced additional analyses from its pivotal Phase 3 IMPALA-2 clinical trial of molgramostim in aPAP were presented as poster presentations at the EERS Congress 2025 in Amsterdam, The Netherlands. Prespecified analyses were conducted to determine if the beneficial clinical effects of molgramostim inIMPALA-2, a Phase 3 clinical trial, were similar in patients with aPAP based on their disease severity as measured by hemoglobin-adjusted percent predicted diffusing capacity of the lungs for carbon monoxide, or DLco% (50% or >50%) at randomization; Molgramostim demonstrated improvement compared with placebo on the primary endpoint, change in DLco% from baseline to Week 24, in patients with aPAP regardless of disease severity; Molgramostim significantly improved measures of pulmonary gas transfer (DLco%), respiratory health-related quality of life (St. George's Respiratory Questionnaire [SGRQ] Total and Activity scores), and patient functionality (exercise capacity expressed as peak metabolic equivalents [METs) compared with placebo in both subgroups of patients with DLco% values of 50% or >50% at randomization; Molgramosterim demonstrated improvement compared with placebo On the primary endpoint, change inDLco% from baseline to Week24, in patients with aP AP regardless of disease severity; Mol gramsostim significantly improved measures of lung gas transfer (DLco%), lung health-related quality of life; and patient functionality (exercise capability expressed as peak metabolic equivalents [mets) compared with placebo in all subgroups of patients with DLCo% values of 50% or =50% at randomization; and Surfactant Burden in Autoimmune Pulmonary Alveolar Proteinosis (PAP). DLco% (a measure of pulmonary gas transfer) was chosen as the primary endpoint in the IMPALA-2 Phase 3 clinical trial because it is a standardized measure of pulmonary gas transfer widely used in clinical practice; Previous research has shown that changes in DLco% correlate with changes in aPAP disease severity (i.e.,surfactant accumulation/burden) and may predict the need for whole-lung lavage; Post-hoc correlation analyses of IMPALA-2 data were conducted to evaluate the relationship between DLco% and measures of HRQoL, patient functionality, and surfactant burden in patients with aPAP; Significant negative correlations were observed between DLco% and measures the relationship between DLco% & measures of HRQoL (SGRQ Total and Activity scores; higher scores indicate worse quality of life), as well as DLco% and surfactant accumulation (ground-glass opacity scores; lower scores indicate less surfactant) at Week 24. Significant positive correlations were observed between DLco%. Significant positive correlations were observed betweenDLco% and patient functionality (exercisecapacity expressed as peak METs; higher scores indicate improved exercise capacity) at weeks 24 and 48; Results further support the clinical relevance of changes in DLco% in aPAP; changes in DLco% are associated with changes in clinical outcomes and the extent of pulmonary pathology; and the extent of pulmonary pathology,making it a clinically meaningful measure in this rare lung disease. Aankondiging • Sep 09
Robbins LLP Announces Class Action Lawsuit Against Savara Inc Robbins LLP informed stockholders that a class action was filed on behalf of persons and entities that purchased or otherwise acquired Savara Inc. securities between March 7, 2024 and May 23, 2025. The Allegations: Robbins LLP is Investigating Allegations that Savara Inc. (SVRA) Misled Investors About the Viability of its Lead Drug Candidate. According to the complaint, during the class period, defendants failed to disclose that: (i) the MOLBREEVI Biologics License Application ("BLA") lacked sufficient information regarding MOLBREEVI's chemistry, manufacturing, and/or controls; (ii) accordingly, the FDA was unlikely to approve the MOLBREEVI BLA in its current form; (iii) the foregoing made it unlikely that Savara would complete its submission of the MOLBREEVI BLA within the timeframe it had represented to investors; and (iv) the delay in MOLBREEVI's regulatory approval increased the likelihood that the Company would need to raise additional capital. Plaintiff alleges that on May 27, 2025, Savara issued a press release announcing that the Company received letter from the FDA for the [MOLBREEVI BLA] as a therapy to treat patients with (aPap). Specifically, Savara revealed that upon preliminary review, the FDA determined that the [MOLBREEVI BLA] was not sufficiently complete to permit substantive review and requested additional data related to Chemistry, Manufacturing, and Controls (CMC). On this news, Savara's stock price fell $0.90 per share, or 31.69%, to close at $1.94 per share on May 27, 2025. Price Target Changed • Sep 08
Price target increased by 12% to US$9.36 Up from US$8.36, the current price target is an average from 7 analysts. New target price is 152% above last closing price of US$3.72. Stock is down 13% over the past year. The company is forecast to post a net loss per share of US$0.51 next year compared to a net loss per share of US$0.48 last year. Aankondiging • Aug 19
Savara Inc. to Present New Data from the Phase 3 Impala-2 Trial of Molgramostim Inhalation Solution (Molgramostim) in Patients with Autoimmune Pulmonary Alveolar Proteinosis At the European Respiratory Society Congress 2025 Savara Inc. announced the acceptance of three abstracts for poster presentation at the European Respiratory Society (ERS) Congress 2025, September 27 - October 1, Amsterdam, The Netherlands. The Company will also host an Industry evening Mini Symposium titled "Advances in Autoimmune Pulmonary Alveolar Proteinosis" at the meeting. Molgramostim is delivered via an investigational eFlow®? Nebulizer System (PARI Pharma GmbH) specifically developed for inhalation of a large molecule. management team has significant experience in rare respiratory diseases and pulmonary medicine, identifying unmet needs, and diagnosis and management of the disease. Recent Insider Transactions • Jun 25
Independent Director recently bought US$99k worth of stock On the 20th of June, Richard Hawkins bought around 48k shares on-market at roughly US$2.04 per share. This transaction increased Richard's direct individual holding by 2x at the time of the trade. In the last 3 months, there was an even bigger purchase from another insider worth US$416k. Insiders have collectively bought US$592k more in shares than they have sold in the last 12 months. Price Target Changed • May 29
Price target decreased by 11% to US$8.31 Down from US$9.31, the current price target is an average from 8 analysts. New target price is 271% above last closing price of US$2.24. Stock is down 45% over the past year. The company is forecast to post a net loss per share of US$0.50 next year compared to a net loss per share of US$0.48 last year. Aankondiging • May 28
Savara Receives Refusal to File Letter from the U.S. Food and Drug Administration for the Biologics License Application Savara Inc. announced that the Company received an RTF letter from the FDA for the BLA of MOLBREEVI as a therapy to treat patients with autoimmune PAP. Upon preliminary review, the FDA determined that the BLA submitted in March 2025 was not sufficiently complete to permit substantive review and requested additional data related to Chemistry, Manufacturing, and Controls (CMC). The RTF was not the result of safety concerns, and the FDA did not request or recommend additional efficacy studies. Within the next 30 days, the Company intends to request a Type A meeting with the Agency. Typically, Type A meetings are granted by the FDA within 30 days of the request. The RTF does not impact previous designations granted by regulators for MOLBREEVI in autoimmune PAP. MOLBREEVI in autoimmune PAP has been granted Fast Track and Breakthrough Therapy Designations by the FDA, Orphan Drug Designation by the FDA and the European Medicines Agency (EMA), as well as Innovation Passport (IP) and Promising Innovative Medicine (PIM) designations by the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA). New Risk • May 27
New minor risk - Profitability The company is currently unprofitable and not forecast to become profitable over the next 3 years. Trailing 12-month net loss: US$102m Forecast net loss in 3 years: US$13m This is considered a minor risk. Companies that are not profitable are more likely to be burning through cash and less likely to be well established. Ultimately, shareholders want to see a good return on their investment and that generally comes from sharing in the company's profits. Without profits, the company is under pressure to grow significantly while potentially having to reduce costs and possibly needing to take on debt or raise capital to remain afloat. Currently, the following risks have been identified for the company: Major Risk Revenue is less than US$1m. Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (US$13m net loss in 3 years). Shareholders have been diluted in the past year (19% increase in shares outstanding). New Risk • May 14
New minor risk - Profitability The company is currently unprofitable and not forecast to become profitable over the next 3 years. Trailing 12-month net loss: US$102m Forecast net loss in 3 years: US$3.5m This is considered a minor risk. Companies that are not profitable are more likely to be burning through cash and less likely to be well established. Ultimately, shareholders want to see a good return on their investment and that generally comes from sharing in the company's profits. Without profits, the company is under pressure to grow significantly while potentially having to reduce costs and possibly needing to take on debt or raise capital to remain afloat. Currently, the following risks have been identified for the company: Major Risk Revenue is less than US$1m. Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (US$3.5m net loss in 3 years). Shareholders have been diluted in the past year (19% increase in shares outstanding). Aankondiging • Apr 28
Savara Inc., Annual General Meeting, Jun 05, 2025 Savara Inc., Annual General Meeting, Jun 05, 2025. Recent Insider Transactions • Apr 02
Independent Director recently bought US$416k worth of stock On the 31st of March, David Ramsay bought around 150k shares on-market at roughly US$2.78 per share. This transaction amounted to 6.5% of their direct individual holding at the time of the trade. This was the largest purchase by an insider in the last 3 months. Insiders have collectively bought US$472k more in shares than they have sold in the last 12 months. Price Target Changed • Mar 31
Price target increased by 8.3% to US$10.36 Up from US$9.56, the current price target is an average from 8 analysts. New target price is 274% above last closing price of US$2.77. Stock is down 43% over the past year. The company is forecast to post a net loss per share of US$0.51 next year compared to a net loss per share of US$0.48 last year. Board Change • Mar 27
Insufficient new directors No new directors have joined the board in the last 3 years. The company's board is composed of: No new directors. 7 experienced directors. 3 highly experienced directors. Member of Clinical Advisory Board Cormac McCarthy was the last director to join the board, commencing their role in 2021. The following issues are considered to be risks according to the Simply Wall St Risk Model: Insufficient board refreshment. Aankondiging • Mar 27
Savara Inc. Completes Submission of the Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for MOLBREEVI as Treatment for Autoimmune Pulmonary Alveolar Proteinosis (aPAP) Savara Inc. announced that it has completed submission of the BLA to the FDA for MOLBREEVI as a treatment for aPAP. The IMPALA-2 trial met its primary endpoint, with MOLBREEVI achieving statistically significant improvement from baseline in percent predicted diffusing capacity of the lungs for carbon monoxide (DLCO), a well-established measure of pulmonary gas exchange, compared to placebo at Week 24. This significant improvement was sustained at Week 48 (a secondary endpoint), demonstrating durability of treatment effect. In addition to gas exchange improvement, trial results provided evidence of clinical benefit as measured by improvements in the St. George’s Respiratory Questionnaire (SGRQ) Total and Activity Scores and Exercise Capacity as measured by an exercise treadmill test and expressed as peak METs (metabolic equivalents, an established measure of exercise capacity). MOLBREEVI showed evidence of clinical benefit for all three secondary endpoints, as demonstrated by statistically significant improvements in SGRQ Total Score at Week 24, and numerically greater improvements in the MOLBREEVI group compared to placebo for SGRQ Activity Score and Peak METs at Weeks 24 and 48. MOLBREEVI was well-tolerated in the IMPALA-2 trial, with 97% of patients completing the double-blind period of the trial and no discontinuations from adverse events that were considered drug-related. 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). 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. 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. Aankondiging • Mar 18
Savara Inc. to Present New Data from the Phase 3 IMPALA-2 Trial of Molgramostim Inhalation Solution (Molgramostim) in Patients with Autoimmune Pulmonary Alveolar Proteinosis (aPAP) at the American Thoracic Society International Conference 2025 Savara Inc. announced the acceptance of two abstracts for poster presentation at the American Thoracic Society (ATS) International Conference taking place May 16-21, 2025, in San Francisco, CA. The Company will also host an Industry Theater titled "Advances in Autoimmune Pulmonary Alveolar Proteinosis (aPAP)" at the meeting. ATS 2025 Posters: Molgramostim Reduces Surfactant Burden and Number of Whole Lung Lavage Procedures in Patients with Autoimmune Pulmonary Alve solar Proteinosis (aPAP): Results From the IMPALA-2 Phase 3 Clinical Trial Session Title: A24 - Updates in Rare Lung Disease, Sarcoidosis, and Lung Transplant. Date/Time of Poster Discussion Session: Sunday, May 18, 2025, 9:15 - 11:15 AM PT, Location: PD05. Presenter: Tisha S. Wang, M.D., Professor of Clinical Medicine, Senior Executive Clinical Vice Chair, University of California Los Angeles Department of Medicine. The abstracts will be published in a supplement of the American Journal of Respiratory and Critical Care Medicine on May 1, 2025. Aankondiging • Mar 06
Savara Inc. Announces U.S. Launch of the Apap Clearpath™? Dried Blood Spot Test to Detect Autoimmune Pulmonary Alveolar Proteinosis Savara Inc. announced the launch of the aPAP ClearPath Dried Blood Spot (DBS) Test in the U.S., an evolution of the first serum-based assay the Company launched. The DBS test helps obtain a diagnosis of aPAP, a rare autoimmune lung disease caused by antibodies targeting GM-CSF, with only a finger-prick blood sample. The DBS test demonstrates a high correlation between GM-CSF autoantibody levels in dried serum and traditional serum samples, ensuring reliable results, and has achieved 100% analytical sensitivity and specificity in a cohort of individuals with confirmed GM-CSF autoantIBody status. The Company partnered with TrilliumBiO, a health solutions provider with a Clinical Laboratory Improvement Amendments (CLIA)-certified lab, to develop and validate the simple, no-cost, and noninvasive test. Only a physician or healthcare provider can order the test and make a diagnosis of aPAP. New Risk • Feb 18
New minor risk - Insider selling There has been significant insider selling in the company's shares over the past 3 months. Total value of shares sold: US$291k This is considered a minor risk. There are several reasons why an insider may be selling, including to cover a tax obligation or pay for some other expense. However, we generally consider it a negative if insiders have been selling, especially if they do so below the current price. It implies that they considered a lower price to be reasonable. This is a weak signal, but if there is a pattern of unexplained selling, it can be a sign the insider believes the company's stock is overpriced. Note: We only include open market transactions and private dispositions of directly owned stock by individuals, not by corporations or trusts. Currently, the following risks have been identified for the company: Major Risk Revenue is less than US$1m. Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (US$16m net loss in 3 years). Shareholders have been diluted in the past year (20% increase in shares outstanding). Significant insider selling over the past 3 months (US$291k sold). Aankondiging • Jan 30
Savara Inc. Announces Manuscript on Long-Term Outcomes with Molgramostim Inhalation Solution (Molgramostim) in Autoimmune Pulmonary Alveolar Proteinosis (aPAP) Published in ERJ Open Research Savara Inc. announced a manuscript titled, "Long-Term Outcomes in Five Patients with Autoimmune Pulmonary Alveolar Proteinosis Treated with Molgramostim Inhalation Solution" was published online in the journal ERJ Open Research. The outcomes data presented suggest that treatment with molgramostim addresses the underlying pathophysiology of aPAP, resulting in improved lung function, decreased disease burden, restored patient functionality, and reduction of clinical symptoms, and may enable resumption of daily life activities. This case series retrospectively evaluated five aPAP patients who received molgramostim through European single-patient access, supplied by Savara. Following treatment with molgramostim (mean duration of 4.2 years), improvements in disease severity were shown across pulmonary gas transfer, measured by percent predicted differences of the lung for carbon monoxide (DLco) and alveolar-arterial oxygen gradient (A-aDO2), as well as activities of daily living. Additionally, surfactant burden was reduced as indicated by high-resolutionputed tomography scans taken before and after molgramostim treatment. In the long-term, the disease can lead to serious complications, including lung fibrosis and the need for a lung transplant. Aankondiging • Dec 19
Savara Inc. Initiates Rolling Submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for MOLBREEVI* for the Potential Treatment of Autoimmune Pulmonary Alveolar Proteinosis (aPAP) Savara Inc. initiated a rolling submission of a BLA to the FDA for MOLBREEVI for the potential treatment of aPAP, a chronic and debilitating rare lung disease characterized by the abnormal build-up of surfactant in the alveoli of the lungs. MOLBREEVI was granted Fast Track and Breakthrough Therapy Designations in 2019 for the treatment of patients with aPAP. As a result, the Company is allowed to submit individual modules of the BLA as they are completed rather than waiting to submit the application once all modules are available. The Company will request a priority review of the BLA when the submission is completed. 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 by the European Medicines Agency (EMA), Innovation Passport (IP) and Promising Innovative Medicine (PIM) designations by the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA). About Autoimmune PAP: Autoimmune PAP is a rare lung disease characterized by the abnormal build-up of surfactant in the alveoli (or air sacs) 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. Recent Insider Transactions • Dec 18
Chairman & CEO recently sold US$181k worth of stock On the 16th of December, Matthew Pauls sold around 55k shares on-market at roughly US$3.31 per share. This transaction amounted to 7.4% of their direct individual holding at the time of the trade. This was the largest sale by an insider in the last 3 months. Matthew has been a net seller over the last 12 months, reducing personal holdings by US$577k. Recent Insider Transactions Derivative • Dec 17
Chairman & CEO notifies of intention to sell stock Matthew Pauls intends to sell 55k shares in the next 90 days after lodging an Intent To Sell Form on the 16th of December. If the sale is conducted around the recent share price of US$3.31, it would amount to US$181k. For the year to December 2017, Matthew's total compensation was 16% salary and 84% other compensation. This indicates that these sales could comprise a meaningful part of their income for the year. Since December 2023, Matthew has owned 508.67k shares directly. Company insiders have collectively sold US$469k more than they bought, via options and on-market transactions in the last 12 months. Recent Insider Transactions • Nov 20
Independent Director recently bought US$288k worth of stock On the 18th of November, David Ramsay bought around 100k shares on-market at roughly US$2.88 per share. This transaction amounted to 4.5% of their direct individual holding at the time of the trade. This was the largest purchase by an insider in the last 3 months. Despite this recent purchase, insiders have collectively sold US$344k more in shares than they bought in the last 12 months. New Risk • Nov 15
New minor risk - Profitability The company is currently unprofitable and not forecast to become profitable over the next 3 years. Trailing 12-month net loss: US$83m Forecast net loss in 3 years: US$7.6m This is considered a minor risk. Companies that are not profitable are more likely to be burning through cash and less likely to be well established. Ultimately, shareholders want to see a good return on their investment and that generally comes from sharing in the company's profits. Without profits, the company is under pressure to grow significantly while potentially having to reduce costs and possibly needing to take on debt or raise capital to remain afloat. Currently, the following risks have been identified for the company: Major Risk Revenue is less than US$1m. Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (US$7.6m net loss in 3 years). Shareholders have been diluted in the past year (27% increase in shares outstanding). Price Target Changed • Nov 14
Price target decreased by 7.9% to US$9.93 Down from US$10.79, the current price target is an average from 7 analysts. New target price is 211% above last closing price of US$3.19. Stock is down 12% over the past year. The company is forecast to post a net loss per share of US$0.45 next year compared to a net loss per share of US$0.33 last year. New Risk • Nov 12
New minor risk - Profitability The company is currently unprofitable and not forecast to become profitable over the next 3 years. Trailing 12-month net loss: US$75m Forecast net loss in 3 years: US$3.0m This is considered a minor risk. Companies that are not profitable are more likely to be burning through cash and less likely to be well established. Ultimately, shareholders want to see a good return on their investment and that generally comes from sharing in the company's profits. Without profits, the company is under pressure to grow significantly while potentially having to reduce costs and possibly needing to take on debt or raise capital to remain afloat. Currently, the following risks have been identified for the company: Major Risk Revenue is less than US$1m. Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (US$3.0m net loss in 3 years). Shareholders have been diluted in the past year (22% increase in shares outstanding). Aankondiging • Oct 04
Savara Appoints Braden Parker as Chief Commercial Officer Savara announced the appointment of Braden Parker as Chief Commercial Officer. Parker is a seasoned global commercial leader with more than 25 years of experience in the healthcare and biotech industry. Throughout his career, he has developed and executed global commercial plans, including market expansion activities, built high-performance teams, and launched multiple successful rare disease products. Parker is responsible for overseeing Savara's global commercial strategy for molgramostim inhalation solution (molgramostim) in autoimmune Pulmonary Alveolar Proteinosis (aPAP). Parker joins Savara from Orchard Therapeutics (Kyowa Kirin), where he served as Chief Commercial Officer. In this role, he was responsible for global commercial strategy and execution for the company's unique ex-vivo autologous HSC gene therapy product portfolio, including overseeing Orchard Therapeutics' first product launch, Libmeldy, for the treatment of metachromatic leukodystrophy (MLD), a rare hereditary disease. Prior to joining Orchard Therapeutics, he served as Vice President and General Manager for the U.S. organization for PTC Therapeutics and led the company's first U.S. product launch in Duchenne muscular dystrophy. Earlier in his career, Parker held commercial leadership roles at Celgene and NPS Pharma (Shire). Savara added it plans to complete submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for molgramostim for the treatment of aPAP in the first half of 2025. Price Target Changed • Jun 27
Price target increased by 19% to US$10.71 Up from US$9.00, the current price target is an average from 7 analysts. New target price is 181% above last closing price of US$3.81. Stock is up 41% over the past year. The company is forecast to post a net loss per share of US$0.41 next year compared to a net loss per share of US$0.33 last year. Aankondiging • Jun 26
Savara Inc. Announces Positive Results from the Pivotal, Phase 3 IMPALA-2 clinical trial Savara Inc. announced positive results from the pivotal, Phase 3 IMPALA-2 clinical trial. IMPALA-2 is a 48-week, randomized, double-blind, placebo-controlled trial assessing the efficacy and safety of molgramostim 300 mcg administered once daily by inhalation with matching placebo in adult patients with aPAP (NCT04544293). Molgramostim is an inhaled form of recombinant human granulocyte-macrophage colony-stimulating factor (GM-CSF). The trial met its primary endpoint. The treatment difference between molgramostim and placebo for mean change from baseline to Week 24 in hemoglobin-adjusted percent predicted DLCO achieved statistical significance. This statistically significant treatment difference was sustained at Week 48, a secondary endpoint, which demonstrated durability of effect. The treatment difference between molgramostim and placebo for mean change from baseline to Week 24 in SGRQ Total Score achieved statistical significance. Two additional secondary endpoints reached nominal significance: SGRQ Activity Score at Week 24 and exercise capacity using a treadmill test at Week 48. Molgramostim was well tolerated. The frequency of adverse events was generally similar between treatment groups. Two patients (2.5%) discontinued molgramostim treatment due to adverse events, both of which were considered unrelated to trial drug. The most commonly reported adverse events in the molgramostim group were COVID-19, cough, and pyrexia, with COVID-19 occurring more frequently with molgramostim than with placebo. Molgramostim has been granted Orphan Drug, Fast Track, and Breakthrough Therapy designation from the U.S. Food and Drug Administration, Orphan Drug designation from the European Medicines Agency and Innovative Passport and Promising Innovative Medicine designation from the UK's Medicines and Healthcare Products Regulatory Agency for the treatment of aPAP. Aankondiging • May 11
Savara Inc. has filed a Follow-on Equity Offering in the amount of $100 million. Savara Inc. has filed a Follow-on Equity Offering in the amount of $100 million.
Security Name: Common Stock
Security Type: Common Stock
Transaction Features: At the Market Offering Aankondiging • Apr 28
Savara Inc., Annual General Meeting, Jun 06, 2024 Savara Inc., Annual General Meeting, Jun 06, 2024, at 15:00 US Eastern Standard Time. Agenda: To elect six directors to hold office until the next annual meeting of stockholders and until their respective successors are elected and qualified or until their earlier resignation or removal; to approve the Savara Inc. 2024 Omnibus Incentive Plan; to approve an amendment to our Amended and Restated Certificate of Incorporation to allow for exculpation of officers as permitted by Delaware law; to ratify the appointment of RSM US LLP as independent registered public accounting firm for the fiscal year ending December 31, 2024; to approve, on an advisory basis, the compensation of named executives; and to transact such other business as may properly come before the Annual Meeting and any adjournment or postponement thereof. Aankondiging • Apr 13
Dr. Ricky Sun Notifies the Board of Directors of Savara Inc. of His Intention Not to Stand for Reelection On April 10, 2024, Dr. Ricky Sun notified the Board of Directors of Savara Inc. of his intention not to stand for reelection to the Board following the expiration of his current term at the 2024 Annual Meeting of Stockholders. Dr. Sun will continue to serve as a director and a member of the Nominating and Governance Committee of the Board until the Annual Meeting. Dr. Sun’s decision not to stand for reelection was not the result of any dispute or disagreement with the Company on any matter relating to its operations, policies, or practices. Aankondiging • Apr 09
Savara to Present New Data on Autoimmune Pulmonary Alveolar Proteinosis at the American Thoracic Society International Conference 2024 Savara Inc. announced the acceptance of two abstracts for poster presentation at the American Thoracic Society (ATS) 2024 International Conference, taking place May 17-22, 2024, in San Diego, CA. Savara: 701: Healthcare Burden of Pulmonary Alveolar Proteinosis Poster Session A26: Improving Outcomes in Sarcoidosis, Rare Lung Disease and Lung Transplant. Poster Discussion Session: May 19, 2024, 9:15-11:15 AM PDT. Trillium Health; 702: Development of a Novel Laboratory Test for the Detection of GM-CSF Antibodies to Aid in the Diagnosis of Individuals At-Risk for Autoimmune Pulmonary Alveolar Proteinosis (aPAP). Poster Session A26: Improving Outcomes in Sarcoidosis, Rare Lung Disease and Lung Transplant Poster Discussion Session: May 19, 2024, 9:15-11:15 AM PDT.The abstracts will be published in a supplement of theAmerican Journal of Respiratory and Critical Care Medicine (AJRCCM) on May 1, 2024. Breakeven Date Change • Mar 08
No longer forecast to breakeven The 7 analysts covering Savara no longer expect the company to break even during the foreseeable future. The company was expected to make a profit of US$16.4m in 2026. New consensus forecast suggests the company will make a loss of US$13.3m in 2026. New Risk • Mar 04
New minor risk - Profitability The company is currently unprofitable and not forecast to become profitable over the next 3 years. Trailing 12-month net loss: US$49m Forecast net loss in 3 years: US$33m This is considered a minor risk. Companies that are not profitable are more likely to be burning through cash and less likely to be well established. Ultimately, shareholders want to see a good return on their investment and that generally comes from sharing in the company's profits. Without profits, the company is under pressure to grow significantly while potentially having to reduce costs and possibly needing to take on debt or raise capital to remain afloat. Currently, the following risks have been identified for the company: Major Risk Revenue is less than US$1m. Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (US$33m net loss in 3 years). Shareholders have been diluted in the past year (19% increase in shares outstanding). Significant insider selling over the past 3 months (US$632k sold). Recent Insider Transactions • Jan 01
Chairman & CEO recently sold US$396k worth of stock On the 28th of December, Matthew Pauls sold around 84k shares on-market at roughly US$4.71 per share. This transaction amounted to 14% of their direct individual holding at the time of the trade. This was the largest sale by an insider in the last 3 months. This was Matthew's only on-market trade for the last 12 months. Breakeven Date Change • Dec 31
Forecast to breakeven in 2026 The 6 analysts covering Savara expect the company to break even for the first time. New consensus forecast suggests the company will make a profit of US$47.7m in 2026. Average annual earnings growth of 58% is required to achieve expected profit on schedule. Aankondiging • Dec 21
Savara Inc. Introduces Apap Clearpath, A Gm-Csf Autoantibody Blood Test to Detect Autoimmune Pulmonary Alveolar Proteinosis Savara Inc. launched aPAP ClearPath, a new serum-based blood test that can be used by physicians in the U.S. to obtain a definitive diagnosis of aPAP, a rare autoimmune lung disease mediated by autoantibodies targeting GM-CSF. Autoimmune PAP accounts for approximately 90% of all patients with PAP and has an estimated diagnosed prevalence of seven cases per million in the U.S. and similar or higher prevalence reported elsewhere in the world. The aPAP ClearPath test is a highly sensitive and specific quantitative immunoassay designed to detect aPAP GM-CSF autoantibodies in human serum. The Company partnered with Trillium Health (trillium-health.com), a modern health solutions provider and a Clinical Laboratory Improvement Amendments (CLIA)-certified lab, to develop the simple, no-cost, and noninvasive test. Only a physician or healthcare provider can make a diagnosis of aPAP. New Risk • Nov 10
New minor risk - Profitability The company is currently unprofitable and not forecast to become profitable over the next 3 years. Trailing 12-month net loss: US$49m Forecast net loss in 3 years: US$15m This is considered a minor risk. Companies that are not profitable are more likely to be burning through cash and less likely to be well established. Ultimately, shareholders want to see a good return on their investment and that generally comes from sharing in the company's profits. Without profits, the company is under pressure to grow significantly while potentially having to reduce costs and possibly needing to take on debt or raise capital to remain afloat. Currently, the following risks have been identified for the company: Major Risk Revenue is less than US$1m. Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (US$15m net loss in 3 years). Shareholders have been diluted in the past year (19% increase in shares outstanding). Breakeven Date Change • Nov 09
No longer forecast to breakeven The 6 analysts covering Savara no longer expect the company to break even during the foreseeable future. The company was expected to make a profit of US$9.46m in 2025. New consensus forecast suggests the company will make a loss of US$2.04m in 2025. Price Target Changed • Aug 14
Price target increased by 7.3% to US$5.50 Up from US$5.13, the current price target is an average from 5 analysts. New target price is 44% above last closing price of US$3.82. Stock is up 127% over the past year. The company is forecast to post a net loss per share of US$0.29 next year compared to a net loss per share of US$0.25 last year. Price Target Changed • Aug 11
Price target increased by 7.5% to US$5.38 Up from US$5.00, the current price target is an average from 4 analysts. New target price is 39% above last closing price of US$3.88. Stock is up 127% over the past year. The company is forecast to post a net loss per share of US$0.30 next year compared to a net loss per share of US$0.25 last year. New Risk • Jul 16
New minor risk - Shareholder dilution The company's shareholders have been diluted in the past year. Increase in shares outstanding: 18% This is considered a minor risk. Shareholder dilution occurs when there is an increase in the number of shares on issue that is not proportionally distributed between all shareholders. Often due to the company raising equity capital or some options being converted into stock. All else being equal, if there are more shares outstanding then each existing share will be entitled to a lower proportion of the company's total earnings, thus reducing earnings per share (EPS). While dilution might not always result in lower EPS (like if the company is using the capital to fund an EPS accretive acquisition) in a lot cases it does, along with lower dividends per share and less voting power at shareholder meetings. Currently, the following risks have been identified for the company: Major Risk Revenue is less than US$1m. Minor Risks Share price has been volatile over the past 3 months (10% average weekly change). Shareholders have been diluted in the past year (18% increase in shares outstanding). New Risk • Jul 14
New minor risk - Share price stability The company's share price has been volatile over the past 3 months. It is more volatile than 75% of American stocks, typically moving 10% a week. This is considered a minor risk. Share price volatility indicates the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. It also increases the risk of potential losses in the short term as the stock tends to have larger drops in price more frequently than other stocks. Currently, the following risks have been identified for the company: Major Risk Revenue is less than US$1m. Minor Risk Share price has been volatile over the past 3 months (10% average weekly change). Aankondiging • Jun 27
Savara Inc. Completes Enrollment of Pivotal Phase 3 Impala-2 Trial of Molgramostim Nebulizer Solution (Molgramostim) in Autoimmune Pulmonary Alveolar Proteinosis Savara Inc. announced that enrollment has been completed for the pivotal Phase 3 IMPALA-2 trial. A total of 164 patients were randomized. Target enrollment for the trial was 160 patients. The Company expects to report top line results by the end of second quarter 2024. IMPALA-2 is a global, 48-week, placebo-controlled clinical trial evaluating molgramostim, a novel inhaled biologic, for the treatment of aPAP, a rare lung disease with no approved pharmacological treatments. In December 2019, the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy Designation for molgramostim in aPAP based on data from the double-blind treatment period of the Phase 2/3 IMPALA clinical trial. Initiation of IMPALA-2 was based on results from IMPALA which were published in the New England Journal of Medicine in September 2020. In 2022, the UK'sMedicines and Healthcare Products Regulatory Agency (MHRA) granted Promising Innovative Medicine (PIM) designation and Innovative Passport Designation to molgramostim for the treatment of aP AP. About the IMPALA-2 Trial IMPALA-2 is an global, pivotal, Phase 3, 48-week, randomized, double-blind, placebo-controlled clinical trial designed to compare the efficacy and safety of molgramostim 300 mcg administered once daily by inhalation with matching placebo in patients with aPAP. The trial is being conducted at approximately 50 clinical trial sites in 18 countries across North America, Europe, Japan, South Korea, and Australia. The primary efficacy variable is change from baseline in% predicted diffusing capacity for carbon monoxide (DLCO), a gas exchange measure. Three secondary efficacy variable evaluate clinical measures of direct patient benefit: St. George's Respiratory Questionnaire (SGRQ) Total Score, SGRQ Activity Component Score, and exercise capacity using a treadmill test. Recent Insider Transactions • May 28
Independent Director recently bought US$259k worth of stock On the 26th of May, David Ramsay bought around 100k shares on-market at roughly US$2.59 per share. This transaction amounted to 4.8% of their direct individual holding at the time of the trade. This was the largest purchase by an insider in the last 3 months. Insiders have collectively bought US$1.1m more in shares than they have sold in the last 12 months. Breakeven Date Change • May 17
No longer forecast to breakeven The 4 analysts covering Savara no longer expect the company to break even during the foreseeable future. The company was expected to make a profit of US$10.8m in 2025. New consensus forecast suggests the company will make a loss of US$10.6m in 2025. Price Target Changed • May 16
Price target increased by 21% to US$4.60 Up from US$3.80, the current price target is an average from 5 analysts. New target price is 132% above last closing price of US$1.98. Stock is up 50% over the past year. The company is forecast to post a net loss per share of US$0.31 next year compared to a net loss per share of US$0.25 last year. Aankondiging • Feb 16
Savara Inc. Announces New Leadership Appointments Savara Inc. announced the appointments of two pharmaceutical industry veterans to its executive leadership team. Rob Lutz has been appointed Chief Operating Officer, effectively immediately. Scott Wilhoit was appointed Executive Vice President, Global Commercial, effective January 9, 2023, and Dave Lowrance was promoted from Chief Financial Officer to Chief Financial and Administrative Officer, effective December 13, 2022. From March 2021 to February 2023, Mr. Lutz, age 54, served as the Chief Financial and Business Officer of iBio Inc. (“iBio”), a biotechnology company developing precision antibody immunotherapies using an AI-driven platform. Previously, Mr. Lutz was employed by Strongbridge Biopharma plc (“Strongbridge”), a biopharmaceutical company focused on therapies that target rare diseases, where he served as Chief Financial Officer from August 2019 to March 2021 and as Chief Business Officer from October 2014 to August 2019. Prior to joining Strongbridge, Mr. Lutz worked from December 2004 to May 2014 at Shire Plc, a publicly traded specialty biopharmaceutical company prior to being purchased by Takeda Pharmaceutical Company Ltd., where he most recently served as Vice President and held key leadership positions in the Specialty Pharmaceutical division. Prior to Shire Plc, Mr. Lutz worked in a variety of roles, including Vice President of Finance, for Cinergy Corp., an electric and gas utility company. Mr. Lutz also worked as a Senior Analyst at Alan B. Slifka and Co., a hedge fund, after having started his career at Goldman Sachs Group Inc., where he served as a Financial Analyst in its principal investment area. He holds a B.A. in Economics and Computer Science from Amherst College and an M.B.A. from the Kellogg School of Management. Recent Insider Transactions • Jan 05
Independent Director recently bought US$56k worth of stock On the 30th of December, David Ramsay bought around 36k shares on-market at roughly US$1.54 per share. This transaction amounted to 1.7% of their direct individual holding at the time of the trade. In the last 3 months, they made an even bigger purchase worth US$82k. Insiders have collectively bought US$858k more in shares than they have sold in the last 12 months. Breakeven Date Change • Dec 31
Forecast to breakeven in 2025 The 4 analysts covering Savara expect the company to break even for the first time. New consensus forecast suggests the company will make a profit of US$10.8m in 2025. Average annual earnings growth of 57% is required to achieve expected profit on schedule. Recent Insider Transactions • Dec 22
Independent Director recently bought US$82k worth of stock On the 20th of December, David Ramsay bought around 55k shares on-market at roughly US$1.50 per share. This transaction amounted to 2.8% of their direct individual holding at the time of the trade. In the last 3 months, they made an even bigger purchase worth US$187k. Insiders have collectively bought US$767k more in shares than they have sold in the last 12 months. Recent Insider Transactions • Nov 23
Independent Director recently bought US$68k worth of stock On the 21st of November, David Ramsay bought around 50k shares on-market at roughly US$1.37 per share. This transaction amounted to 2.7% of their direct individual holding at the time of the trade. In the last 3 months, they made an even bigger purchase worth US$187k. Insiders have collectively bought US$866k more in shares than they have sold in the last 12 months. Recent Insider Transactions • Sep 28
Independent Director recently bought US$187k worth of stock On the 27th of September, David Ramsay bought around 135k shares on-market at roughly US$1.39 per share. This transaction amounted to 7.8% of their direct individual holding at the time of the trade. This was the largest purchase by an insider in the last 3 months. Insiders have collectively bought US$1.2m more in shares than they have sold in the last 12 months. Recent Insider Transactions • Sep 02
Independent Director recently bought US$142k worth of stock On the 1st of September, David Ramsay bought around 100k shares on-market at roughly US$1.42 per share. This transaction amounted to 6.2% of their direct individual holding at the time of the trade. This was the largest purchase by an insider in the last 3 months. Insiders have collectively bought US$971k more in shares than they have sold in the last 12 months. Recent Insider Transactions • Jun 23
Independent Director recently bought US$138k worth of stock On the 22nd of June, David Ramsay bought around 100k shares on-market at roughly US$1.38 per share. This was the largest purchase by an insider in the last 3 months. Insiders have collectively bought US$976k more in shares than they have sold in the last 12 months. Price Target Changed • Feb 09
Price target increased to US$4.50 Up from US$3.80, the current price target is an average from 5 analysts. New target price is 254% above last closing price of US$1.27. Stock is down 37% over the past year. The company is forecast to post a net loss per share of US$0.32 next year compared to a net loss per share of US$0.84 last year.