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Corporate Overview Developing New
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use of words such as "expect," "intend," "plan," "anticipate," "believe," and "will," among others. Such statements include, but are not limited to, statements regarding the
potential health benefits and risks and projected development timeline of MOLBREEVI; the timing of regulatory submissions; the potential for and impact of regulatory approval; the potential addressable patient population, market size, commercial
opportunity, and competitive landscape for MOLBREEVI; Savara's commercial launch planning activities, including disease awareness campaign, planned infrastructure, and anticipated hiring and the potential impact of those activities; GM-CSF
autoantibody testing and its potential impact; and the sufficiency of our resources to fund the advancement of our development program and potential sources of additional capital. Savara may not actually achieve any of its plans or product
development goals in a timely manner, if at all, or otherwise carry out its current intentions or meet the expectations or projections disclosed in its 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 and geopolitical conditions on our business and operations; risks and uncertainties associated with the ability to project future cash
utilization and reserves needed for contingent future liabilities and business operations; the ability to successfully conduct clinical trials for our product candidate; the availability of sufficient resources and the timing and ability of Savara
to raise additional capital as needed to fund continued operations. The risks and uncertainties facing Savara are described more fully in Savara's filings with the Securities and Exchange Commission, including our filings on Form 8-K, our Annual
Report on Form 10-K for the fiscal year ended December 31, 2024, and our Quarterly Report on Form 10-Q for the quarter ended June 30, 2025. You are cautioned not to place undue reliance on our 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. Third-party information
included herein has been obtained from sources believed to be reliable, but the accuracy or completeness of such information is not guaranteed by, and should not be construed as a representation by, the Company. Additionally, this presentation
includes internal research and estimates performed by the Company, which have not been independently verified. MOLBREEVI (molgramostim inhalation solution) is an investigational product that has not been approved for sale or
determined to be safe or effective by the U.S. Food & Drug Administration or any regulatory authority. MOLBREEVI, MY MOLBREEVI and aPAP ClearPath are trademarks of Savara. All other trademarks included herein are the property of the owners
thereof and are used for reference purposes only.
Executive Leadership Team
Parker, M.B.A. Chief Commercial Officer Ray Pratt, M.D. FACP Chief Medical Officer Sid Advant, Ph.D. EVP, Global Technical Operations Yasmine Wasfi, M.D., Ph.D. EVP, Clinical Operations/Development Brian Robinson, M.D. EVP, Global Medical Affairs
Kate McCabe Chief Legal Officer Charles LaPree EVP, Global Regulatory Affairs
Autoimmune Pulmonary Alveolar
Autoimmune PAP: Disease of Alveolar
NORMAL vs ABNORMAL ALVEOLUS Surfactant accumulation blocks movement of oxygen from the alveoli into the blood Reduced blood oxygenation results in difficulty breathing and, ultimately, hypoxemic respiratory failure Rare lung disease caused by GM-CSF
autoantibodies which block GM-CSF signaling and reduce surfactant clearance Autoimmune PAP GM-CSF Autoantibodies GM-CSF GM-CSF autoantibodies Alveolus in autoimmune PAP Normal Alveolus Thin surfactant layer Thick surfactant layer Alveolar epithelial
cells GM-CSF GM-CSF Normal oxygen delivery Reduced oxygen delivery Foamy alveolar macrophage (lipid filled) Normal alveolar macrophage Air-filled alveolus Surfactant-filled alveolus
Autoimmune PAP is a Rare, Long-Term,
experience shortness of breath At first it occurs upon exertion, but as disease progresses, it can occur even when a person is at rest Cough and Episodes of Fever Cough, sputum production, and episodes of fever, especially if secondary lung
infection develops Serious infections, the most common and threatening complications of autoimmune PAP, occur in 5-13% of patients and account for 18-20% of deaths1-4 Increased Risk of Infection Over time, autoimmune PAP can lead to
pulmonary fibrosis and respiratory failure which can be fatal and may require lung transplantation 1. Trapnell Nat Rev Dis Primers 2019; 2. Seymour AJRCCM 2002; 3. Inoue AJRCCM 2008; 4. Jouneau Respirology 2020 Fibrosis and Lung Transplant Fatigue,
Decreased Exercise Tolerance Fatigue and significantly reduced exercise capacity can dramatically impact the simplest of daily activities, e.g., getting winded walking up a flight of stairs
Requires insertion of double-lumen
endobronchial tube for lung separation Treated lung is repeatedly filled with up to 15-50L of saline and then drained by gravity Patient is percussed to emulsify the surfactant sediment Saline is drained by gravity and continued until lavage fluid
experienced HCPs, and surgical resources Does not correct underlying pathophysiology of the disease or prevent abnormal surfactant accumulation and often needs to be repeated Patients describe WLL as burdensome and emotionally taxing Long-term
negative impact (potential lung damage) of repeated WLL procedures is unknown Sources: 1: Campo, Assessment and Management of PAP in a Reference Center, Orphanet Jour. of Rare Dis., 2013; 2: Campo, Nat. History of PAP Data from Italian Nat.
Reference Center, ERJ, 2019.; Seymour, J. J. Pulmonary alveolar proteinosis: Progress in the First 44 Years, Am. J. Respir Crit. Care Med, 2002. 3: Udwadia, Jain. NEJM (2007) 357:19, 4 McCarthy, Autoimmune Pulmonary Alveolar Proteinosis, Amer.
Journal of Respiratory and Critical Care Med., 2022.
Savara Inc. All Rights
Reserved. Disease Burden: Autoimmune PAP Patients Have Significantly Higher Rates of Healthcare Utilization and Comorbidities1 Charlson Comorbidity Index (CCI)* Outpatient/Inpatient visits (~11 outpatient/~2 inpatient per year) Emergency Room Visits
(~1 per year) Longer hospital stays (~3 days per year) PAP: 1.44 1.96 Age, Gender, Geography Matched Controls: 0.41 1.11 P value: <0.05 PAP: 10.7 10.9 outpatient/ 2.3 7.8 inpatient Age, Gender, Geography Matched
Controls: 4.0 7.0 outpatient/ 0.38 2.5 inpatient P value: <0.001 outpatient/0.001 inpatient PAP: 1.0 2.3 Age, Gender, Geography Matched Controls: 0.29 1.0 P value: <0.001 PAP: 2.8 7.6 Age, Gender, Geography
Matched Controls: 0.56 2.9 P value: <0.001 *Developed to classify comorbid conditions which may influence mortality risk. Most widely used comorbidity index used to determine survival rates in patients with multiple comorbidities. 3.5x Vs.
matched controls +245% Vs. matched controls +167% outpatient +505% inpatient Vs. matched controls 5.0x Vs. matched controls Lee, et al. Orphanet J Rare Dis. 2025; 20:73.
Patient Perspectives on Living with
terms, it's like a car wash for your lungs. Having an alternative treatment from whole lung lavage would mean the world to me, it would give me the opportunity to get my life back. To give me the freedom of what I had before autoimmune PAP. -
Kelsea " " Overall, when the surfactant builds up, I notice how much more tired I get, walking from the basement to the first floor will wind me, I'll get chest congestion and cough up yellow mucus. So, every 8 months surfactant
builds up and I'll need the whole lung lavage, and it causes a lot of anxiety knowing I will need to keep having them. Having had multiple lung lavages over the years; there needs to be more options when it comes to managing autoimmune PAP." -
Disease Burden: Journey of an
2025: Plan to resubmit BLA Symptoms and Experience Before Diagnosis Diagnosis with Autoimmune PAP Treatment CURRENT JOURNEY POTENTIAL FUTURE JOURNEY FROM FIRST EXPERIENCING SYMPTOMS TO SEEING A PHYSICIAN AVERAGE TIME FROM FIRST SEEING A PHYSICIAN TO
DIAGNOSIS 12 MONTHS 18 MONTHS Autoimmune PAP diagnosis Insidious development Battery of diagnostic tests Typically misdiagnosed as pneumonia coupled with incorrect treatment Cycles of misdiagnosis for months to years Eventual referral to a
pulmonologist for full pulmonary work-up Whole lung lavage (WLL) Potential off-label therapies aPAP ClearPath Testing Program Created to reduce barriers to testing and educate physicians and patients on how testing may be used to help confirm or
rule out autoimmune PAP 1. Ataya, et al. J.R.Med.2025 Feb.11:107990 *MOLBREEVI is the FDA and EMA conditionally accepted trade name for molgramostim inhalation solution. It is not approved in any indication.
MOLBREEVI* Savara Inc. All
Rights Reserved. *MOLBREEVI is the FDA and EMA conditionally accepted trade name for molgramostim inhalation solution. It is not approved in any indication. (molgramostim inhalation solution)
Savara Inc. All Rights
Reserved. Once daily 300 g inhaled MOLBREEVI (inhaled biologic) Proprietary eFlow Nebulizer System (PARI) Optimized for MOLBREEVI administration Well-established manufacturer of devices used for inhalation therapy 5 FDA approved
nebulizers based on eFlow Technology Savara Investigational Drug-Device Treatment for Autoimmune PAP Nebulization Time: ~5 minutes
Summary of IMPALA-2 Results
to Week 24 in DLco% (p=0.0007)1 PRIMARY ENDPOINT (MOLBREEVI vs placebo) Change from baseline to Week 48 in DLCO% (p=0.0008)1 SECONDARY ENDPOINTS (MOLBREEVI vs placebo) Change from baseline to Week 24 in SGRQ Total Score (p=0.0072)1 Change from
baseline to Week 24 in SGRQ Activity Score (p=0.0149)2 Change from baseline to Week 48 in Exercise Capacity (p=0.0234)2 Well-tolerated; low treatment discontinuation rate (3%), none due to drug-related adverse events SAFETY and TOLERABILITY 100% of
patients who completed the double-blind period enrolled into the open-label period
Phase 3 IMPALA-2 Trial Design
DLCO at W48 SGRQ Total Score at W24 and W48 SGRQ Activity Score at W24 and W48 Exercise Capacity at W24 and 48 DLCO 70% predicted at first screening and baseline Change in % predicted DLCO <15% points to ensure stably impaired patients
n=81 n=83 BL W48 W24 = Primary efficacy analyses MOLBREEVI 300 g daily dosing placebo MOLBREEVI 300 g daily dosing = Durability of efficacy / safety W144
Discontinuations in Double-Blind
Completers n=79 (97.5%) Week 48 Completers n=80 (96.4%) Treatment Discontinuation 2 AEs* Treatment Discontinuation 1 AE* 1 Pregnancy 1 Lost to follow up Entered Open Label Period n=160** (100%) IMPALA-2 PATIENT DISPOSITION *Not considered trial drug
related **One placebo patient stopped blinded trial drug but continued trial participation through Week 48 and entered the open label period
Demographics in IMPALA-2 Were
African American Other 38 (46.9) 36 (44.4) 3 (3.7) 4 (4.9) 40 (48.2) 37 (44.6) 2 (2.4) 4 (4.8) DLCO at baseline Mean (SD) 52.6 (11.71) 52.6 (10.39) DLCO stratification group 50% > 50% 31 (38.3) 50 (61.7) 32 (38.6) 51 (61.4)
IMPALA-2: MOLBREEVI Superior to PBO
severe COPD.1 MOLBREEVI in autoimmune PAP showed a ~10% increase from baseline at W24 and ~12% increase from baseline at W48. LSM Change from Baseline Between-Group LSM Difference* P-value Week 24 Mol: 9.8 Pbo: 3.8 6.00 0.0007 Week 48 Mol: 11.6 Pbo:
4.7 6.90 0.0008 1 Raghu G, Remy-Jardin M, Richeldi L, et al. Idiopathic Pulmonary Fibrosis (an Update) and Progressive Pulmonary Fibrosis in Adults: An Official ATS/ERS/JRS/ALAT Clinical Practice Guideline. Am J Respir Crit Care Med
2022;205:e18-e47; Horita N, Miyazawa N, Kojima R, Inoue M, Ishigatsubo Y, Kaneko T. Minimum clinically important difference in diffusing capacity of the lungs for carbon monoxide among patients with severe and very severe chronic obstructive
pulmonary disease. COPD 2015;12:31-7. *Mean change from baseline compared with placebo. P-values are for difference in LSM compared with placebo and met the threshold required in the pre-specified hierarchical testing procedure to control the
overall Type 1 error rate at 0.05. DLco%, hemoglobin-adjusted percent predicted diffusing capacity of the lungs for carbon monoxide; LSM, least squares mean; Mol, MOLBREEVI; Pbo, placebo; SE, standard error. Placebo (n=83) MOLBREEVI
IMPALA-2: MOLBREEVI Superior to PBO
Mol: -10.7 Pbo: -5.9 -4.87 0.1046 *Mean change from baseline compared with placebo. P-values are for difference in LSM compared with placebo. Statistically significant: met the threshold required in pre-specified hierarchical testing
procedure to control the overall Type 1 error rate at 0.05. HRQoL, health-related quality of life; LSM, least squares mean; Mol, MOLBREEVI; Pbo, placebo; SE, standard error; SGRQ, St. George's Respiratory Questionnaire. Placebo (n=83)
IMPALA-2: MOLBREEVI Nominally
P-value nominally significant: P-value 0.05 but did not meet the p-value threshold required in the pre-specified hierarchical testing procedure. HRQoL, health-related quality of life; LSM, least squares mean; Mol, MOLBREEVI; Pbo,
placebo; SE, standard error; SGRQ, St. George's Respiratory Questionnaire. LSM Change from Baseline Between-Group LSM Difference* P-value Week 24 Mol: -13.0 Pbo: -5.2 -7.81 0.0149 Week 48 Mol: -13.4 Pbo: -7.4 -5.99 0.1216 Placebo (n=83)
IMPALA-2: MOLBREEVI Nominally
significant: P-value 0.05 but did not meet the p-value threshold required in pre-specified hierarchical testing procedure. LSM, least squares mean; MET, metabolic equivalent; Mol, MOLBREEVI; Pbo, placebo; SE, standard error. Placebo (n=83)
MOLBREEVI (n=81) LSM Change from Baseline Between-Group LSM Difference* P-value Week 24 Mol: 1.11 Pbo: 0.70 0.41 0.0845 Week 48 Mol: 1.13 Pbo: 0.58 0.55 0.0234
IMPALA-2 Demonstrated That
Whole Lung Lavage (WLL) was
IMPALA-2 Safety Summary: MOLBREEVI
related 13 (16) 20 (24) Treatment related1 1 (1) 0 Leading to death 0 0 Leading to trial drug discontinuation 2 (2) 1 (1) Special interest (chest pain, hypersensitivity) 9 (11) 6 (7) Serious and of special interest 0 1 (1) 1SAE of delusions
resulting in psychiatric hospitalization in patient with a past medical history of seizure disorder treated with levetiracetam; the event was assessed as possibly related to study drug by the investigator.
IMPALA-2 Safety Summary: Most
71 (86) Most common COVID-19 18 (22) 8 (10) Cough 17 (21) 18 (22) Pyrexia 11 (14) 9 (11) Nasopharyngitis 11 (14) 7 (8) Arthralgia 9 (11) 7 (8) Headache 9 (11) 7 (8) Diarrhea 9 (11) 2 (2) Alveolar proteinosis 4 (5) 12 (14) Treatment related 20 (25)
Overview of IMPALA-2 Results: Top
48 Weeks 24 and 48 0.0239* 0.0006* Significantly higher proportions of patients achieved each responder threshold (5%, 7%,10%) with MOLBREEVI compared to placebo Respiratory health-related quality of life SGRQ Total Score Week 24 Week 48 0.0072
0.1046 SGRQ Activity Score Responder Analysis - SGRQ Total Week 24 Week 48 Week 24 Week 48 0.0149 0.1216 Numerically (W24) & significantly (W48) higher proportions of patients achieved each responder threshold (-4, -8, -12-points)
with MOLBREEVI compared to placebo Patient functionality Exercise Capacity (Peak METs) Week 24 Week 48 0.0845 0.0234 Surfactant burden Chest Computed Tomography - GGO Week 24 0.0004* Whole Lung Lavage Over 48 Weeks Numerically favorable
to MOLBREEVI compared to placebo *Post-hoc analysis. P-value nominally significant: P-value 0.0500 but did not meet the p-value threshold required in the pre-specified hierarchical testing procedure. DLco%, hemoglobin-adjusted percent
predicted diffusing capacity of the lungs for carbon monoxide; GGO, ground glass opacification; METs, metabolic equivalents; SGRQ, St. George's Respiratory Questionnaire.
Results from IMPALA and IMPALA-2
Real-World, Retrospective Outcomes
R nnov-Jessen I, et al. ERJ Open Res 2025;11:00567-2024. MOLBREEVI treatment led to Improved lung function Decreased disease burden Restored patient functionality Reduced clinical symptoms 0 patients required WLL after >1 year on MOLBREEVI