Slide 1: Corporate Overview
Corporate Overview Developing New Therapies for Rare Respiratory Diseases May 2025 © Savara Inc. All Rights Reserved.
Slide 2: Safe Harbor Statement
Safe Harbor Statement Savara Inc. (“Savara” or the “Company”) cautions you that statements in this presentation that are not a description of historical fact are forward-looking statements which may be identified by the use of words such as “expect,” “intend,” “plan,” “anticipate,” “believe,” and “w
Slide 3: Executive Leadership Team
Executive Leadership Team Matthew Pauls, J.D., M.B.A. Chair & Chief Executive Officer Anne Erickson Dave Lowrance Rob Lutz, M.B.A. Chief Business Officer Chief Financial & Chief Operating Officer Administrative Officer 1zxza Kate McCabe Braden Parker, M.B.A. Ray Pratt, M.D. FACP Chief Legal Officer
Slide 4: Autoimmune Pulmonary Alveolar Proteinosis (aPAP)
Autoimmune Pulmonary Alveolar Proteinosis (aPAP) Overview and Burden of Disease © Savara Inc. All Rights Reserved.
Slide 5: Autoimmune PAP: Disease of Alveolar Macrophage Dysfunction
Autoimmune PAP: Disease of Alveolar Macrophage Dysfunction GM-CSF NORMAL vs ABNORMAL ALVEOLUS aPAP GM-CSF Autoantibodies Alveoli need surfactant to keep from collapsing Rare lung disease caused by GM-CSF autoantibodies which block GM-CSF is critical for alveolar macrophage function and allows for al
Slide 6: Autoimmune PAP is a Rare, Long-Term, Chronic Lung Disease
Autoimmune PAP is a Rare, Long-Term, Chronic Lung Disease No approved drugs in the U.S. or Europe for aPAP, only treatment option is an invasive procedure Progressive Shortness of Breath With impaired gas exchange, patients may experience shortness of breath Increased Risk of Infection At first
Slide 7: A Lung Lavage is an Invasive Procedure Performed in a Tertiary Center
Whole Lung Lavage (WLL): Performed under anesthesia and requires hospitalization, a team of experienced HCPs, and surgical resources A Lung Lavage is an Does not correct underlying pathophysiology of the disease or prevent Invasive Procedure abnormal surfactant accumulation and often needs to be
Slide 8: Disease Burden: Higher Healthcare Utilization and Comorbidities
Disease Burden: Autoimmune PAP Patients Have Significantly Higher Rates of Healthcare Utilization and Comorbidities1 Charlson Comorbidity Index Outpatient/Inpatient visits +167% 3.5x (~11 outpatient/~2 inpatient per year) outpatient (CCI)* Vs. +505% matched inpatient controls Vs. matched controls PA
Slide 9: Patient Perspectives on Living with aPAP
Patient Perspectives on Living with aPAP “ With whole lung lavage being the only treatment option, it’s terrifying. The best way to describe it in layman’s 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
Slide 10: Disease Burden: Journey of an aPAP Patient
Disease Burden: Journey of an aPAP Patient1 CURRENT JOURNEY POTENTIAL FUTURE JOURNEY Symptoms and Experience Diagnosis with aPAP Treatment Before Diagnosis 12 MONTHS 18 MONTHS aPAPClearPath FROM FIRST EXPERIENCING AVERAGE TIME FROM FIRST SYMPTOMS TO SEEING A • Non-invasive, no-cost, simple SEEING A
Slide 11: MOLBREEVI
MOLBREEVI* (molgramostim inhalation solution) *MOLBREEVI is the FDA and EMA conditionally accepted trade name for molgramostim inhalation solution. It is not approved in any indication. © Savara Inc. All Rights Reserved. 11
Slide 12: Savara Investigational Drug-Device Treatment for aPAP
Savara Investigational Drug-Device Nebulization Time: ~5 minutes Treatment for aPAP Once daily 300 µg inhaled MOLBREEVI (inhaled biologic) Proprietary eFlow® Nebulizer System (PARI) • Optimized for MOLBREEVI administration • Well-established manufacturer of devices used for inhalation therapy •
Slide 13: Summary of IMPALA-2 Results
Summary of IMPALA-2 Results PRIMARY ENDPOINT (MOLBREEVI vs placebo) Change from baseline to Week 24 in DLCO% (p=0.0007)1 SECONDARY ENDPOINTS (MOLBREEVI vs placebo) Change from baseline to Week 48 in DLCO% (p=0.0008)1 Change from baseline to Week 24 in SGRQ Total Score (p=0.0072)1 Change from baselin
Slide 14: Phase 3 IMPALA-2 Trial Design
Phase 3 IMPALA-2 Trial Design Period 1: Double-blind Period 2: Open-label (top line) (ongoing, not part of top line results) 6-Week Screening n=81 • DLCO ≤70% predicted MOLBREEVI 300 μg daily dosing at first screening and baseline MOLBREEVI 300 μg daily dosing • Change in % predicted n=83 DLCO <15%
Slide 15: Discontinuations in Double-Blind Period Were Low: 3%
Discontinuations in Double-Blind Period Were Low: 3% Participation in Open Label Period Was High: 100% of Double-Blind Period Completers IMPALA-2 PATIENT DISPOSITION Screened Ineligible Patients (n=122) (n=286) Randomized (n=164) MOLBREEVI Placebo n=81 n=83 Treatment Treatment Discontinuation Discon
Slide 16: Demographics in IMPALA-2 Were Well-Balanced Across Treatment Groups
Demographics in IMPALA-2 Were Well-Balanced Across Treatment Groups MOLBREEVI Placebo N=81 N=83 Age Mean (SD) 50.8 (13.03) 48.4 (12.69) years Sex Male 44 (54.3) 54 (65.1) n (%) Female 37 (45.7) 29 (34.9) Race White 38 (46.9) 40 (48.2) n (%) Asian 36 (44.4) 37 (44.6) Black or African American 3 (3.7)
Slide 17: MOLBREEVI Superior to Placebo on DLCO Change from Baseline
IMPALA-2: MOLBREEVI Superior to PBO on Change from Baseline in DLCO at W24 (primary endpoint) and W48 (secondary endpoint) 15 Molgramostim (N=81) MOLBREEVI (n=81) Placebo (N=83) Change from Baseline Between- LSM Change 10 Group LSM from Baseline P-value LSM ± SE Difference* Week 24 Mol: 9.8 6.00 0.0
Slide 18: MOLBREEVI Superior on SGRQ Total Score at W24
IMPALA-2: MOLBREEVI Superior to PBO on Change From Baseline in SGRQ Total Score at W24, Favorability Continues Through W48 5 Molgramostim (N=81) Placebo (N=83) Change from Baseline 0 Placebo (n=83) Between- LSM Change LSM ± SE -5 Group LSM from Baseline P-value Difference* -10 Week 24 Mol: -11.5 -6.
Slide 19: MOLBREEVI Nominally Significant on SGRQ Activity Score at W24
IMPALA-2: MOLBREEVI Nominally Significant on Change From Baseline in SGRQ Activity Score at W24, Favorability Continues Through W48 Molgramostim (N=81) Placebo (N=83) 5 Change from Baseline 0 LSM Change Between- Placebo (n=83) from Group LSM P-value LSM ± SE -5 Baseline Difference* Week 24 Mol: -13.
Slide 20: MOLBREEVI Nominally Significant on Exercise Capacity at W48
IMPALA-2: MOLBREEVI Nominally Significant on Change From Baseline in Exercise Capacity (Peak METs) at W48 1.5 MOLBREEVI (n=81) Change from Baseline LSM Change Between- 1.0 from Group LSM P-value LSM ± SE Baseline Difference* Week 24 Mol: 1.11 0.41 0.0845 0.5 Placebo (n=83) Pbo: 0.70 Week 48 Mol: 1.1
Slide 21: MOLBREEVI Reduces Pulmonary Surfactant Burden: Ground Glass Opacity Score
IMPALA-2 Demonstrated That MOLBREEVI Reduces Pulmonary Surfactant Burden: Ground Glass Opacity Score at W24 1 p=0.0004* Change From Baseline Baseline 0 Mean ± SE -1 -2 After 24 weeks on -3 MOLBREEVI MOLBREEVI Placebo (N=78) (N=79) *P-value based on post-hoc analysis. GGO, ground glass opacity. © Sav
Slide 22: Whole Lung Lavage Permitted as Rescue Therapy During IMPALA-2
Whole Lung Lavage (WLL) was Permitted as a Rescue Therapy During the IMPALA-2 Trial 17 (~10%) patients underwent at least one lung lavage © Savara Inc. All Rights Reserved. 22
Slide 23: IMPALA-2 Safety Summary: MOLBREEVI Was Well-Tolerated
IMPALA-2 Safety Summary: MOLBREEVI Was Well-Tolerated Treatment Emergent Adverse Events MOLBREEVI Placebo N=81 N=83 n (%) n (%) Any 69 (85) 71 (86) Severe 13 (16) 16 (19) Treatment related 20 (25) 16 (19) Serious 14 (17) 20 (24) Not treatment related 13 (16) 20 (24) Treatment related1 1 (1) 0 Leadin
Slide 24: IMPALA-2 Safety Summary: Most Common Adverse Events
IMPALA-2 Safety Summary: Most Common Adverse Events ADVERSE EVENTS IN >10% OF PATIENTS IN ANY TREATMENT ARM DURING DOUBLE-BLIND TREATMENT PERIOD MOLBREEVI Placebo Treatment Emergent Adverse Events (N=81) (N=83) n (%) n (%) Any 69 (85) 71 (86) Most common COVID-19 18 (22) 8 (10) Cough 17 (21) 18 (22)
Slide 25: Overview of IMPALA-2 Results: Top Line, DSS, Responder Analyses, GGO Data
Overview of IMPALA-2 Results: Top Line, DSS, Responder Analyses, and GGO Data Measure Timeframe P-Value / Results DLCO% Week 24 0.0007 Week 48 0.0008 Disease Severity Score (DSS) Week 24 0.0239* Pulmonary gas exchange Week 48 0.0006* Responder Analysis - DLCO% Weeks 24 and 48 Significantly higher pr
Slide 26: Real-World Retrospective Outcomes Data Suggest MOLBREEVI Addresses Pathophysiology
Real-World, Retrospective Outcomes Data Suggest MOLBREEVI Addresses Underlying Pathophysiology of aPAP Case Series Evaluated 5 aPAP Patients Who Received MOLBREEVI Through Single Patient Access Prior to Treatment ALL 5 PATIENTS RESPONDED TO TREATMENT WITH MOLBREEVI All 5 patients had • CT tomograp
Slide 27: Regulatory and Intellectual Property
Regulatory and Intellectual Property © Savara Inc. All Rights Reserved.
Slide 28: U.S. and European Regulatory Timeline
U.S. and European Regulatory Timeline 2026 2025 2027 2024 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 US Started BLA Rolling Completed BLALA Resubmit BLA Potential Approval* Submission Submission EU MAA Submission Potential Approval UK MAA Submission Potential Approval *Assumes Priority Review is granted
Slide 29: MOLBREEVI in aPAP Regulatory and IP Summary
REGULATORY DESIGNATIONS US Orphan Drug Designation (eligible for 7 years exclusivity) MOLBREEVI in aPAP Fast Track Designation Regulatory and IP Breakthrough Therapy Designation EUROPE Summary Orphan Drug Designation (eligible for 10 years exclusivity) UK Innovation Passport Designation
Slide 30: Commercial Update
Commercial Update © Savara Inc. All Rights Reserved.
Slide 31: Commercial Launch Planning Advancing Against Near-Term Objectives
Commercial Launch Planning Advancing Against Near-Term Objectives AWARENESS INFRASTRUCTURE PERSONNEL TESTING TESTING Expand awareness Build critical of autoimmune PAP capabilities to facilitate Hire and onboard key Evolve diagnostic among targeted access to commercial roles to platform to scale heal
Slide 32: Autoimmune PAP Disease State Awareness Campaign
Autoimmune PAP Disease State Awareness Campaign Multi-channel effort across healthcare professionals and patients HCP DSA Campaign Patient DSA Campaign © Savara Inc. All Rights Reserved. 32
Slide 33: Exclusive Specialty Pharmacy with Integrated Patient Services
Exclusive Specialty Pharmacy with Integrated Patient Services Right-sized model for first-to-market solution for orphan condition SPECIALTY PHARMACY Smaller patient population is best served by a single specialty pharmacy • Consistency • Seamless provision of services • Clear visibility to all pat
Slide 34: MyMolbreevi: Best in Class Support Program in Development
MyMolbreevi: Best in Class Support Program in Development Program aims to reduce access barriers for appropriate MOLBREEVI patients post approval PATIENT SERVICES Case management approach Clinical education Insurance services • Dedicated care navigator • Pharmacist calls • Prior authorization
Slide 35: Studies on aPAP Epidemiology Range From 6-26 Patients P/Million
Studies on aPAP Epidemiology Range From 6-26 Patients P/Million Published aPAP Epidemiology Studies DIAGNOSED IMPLIED IMPLIED IMPLIED TOTAL INCIDENCE REFERENCE METHODOLOGY PREVALENCE US EU* JAPAN IMPLIED PER MILLION PER MILLION PATIENTS PATIENTS PATIENTS PATIENTS DIAGNOSED PREVALENCE Registry based
Slide 36: Significant U.S. Opportunity with ~3,600 Identified aPAP Patients
Significant U.S. Opportunity with ~3,600 Identified aPAP Patients IDENTIFIED aPAP PATIENTS1 HIGHLY LIKELY AND LIKELY aPAP ~3,600 (U.S. Claims Data Analysis) +1,400 Highly likely +2,300 Likely Analysis of comprehensive claims dataset Based on PAP ICD9/10 diagnosis codes from 300M+ Estimate for ad
Slide 37: U.S. Centers Prioritized Based on aPAP Experience
U.S. Centers Prioritized Based on aPAP Experience Goal: Line of Sight to 1,000 Patients at Launch to Maximize Early Launch Phase U.S. PATIENTS / HCP HEATMAP1 COEs† Currently have line of sight to >500 patients ILD Centers* Confirmed location Treating physician Patient management General Pulmon
Slide 38: Overwhelming Support for MOLBREEVI Across Stakeholders
Overwhelming Support for MOLBREEVI Across Stakeholders U.S. PULMONOLOGISTS U.S. PAYERS U.S. PATIENTS 83% 87% 100% Likely to prescribe MOLBREEVI Intend to cover MOLBREEVI with Think new, non-invasive PAP regardless of severity of disease typical Prior Authorization criteria treatments are needed when
Slide 39: Market Development Team
Market Development Team Broadens market reach and accelerates pre-launch activities Head, Market Projected market development team of Development ~25 people (including leadership) Target list of accounts expanded beyond current field medical list to broaden Regional Director Regional Director Re
Slide 40: Claims Data Analysis Suggests U.S. Market May Be 2x Larger
Claims Data Analysis Suggests U.S. Market May Be 2x Larger IDENTIFIED aPAP PATIENTS1 HIGHLY LIKELY AND LIKELY aPAP ~3,600 (U.S. Claims Data Analysis) +1,400 Highly likely Analysis of comprehensive claims dataset +2,300 Likely Based on PAP ICD9/10 diagnosis codes from 300M+ Estimate for additiona
Slide 41: aPAP ClearPath Testing Platform in the U.S.
aPAP ClearPath Testing Platform in the U.S. No cost antibody testing to help confirm or rule out aPAP among undiagnosed patients SERUM TEST DRIED BLOOD SPOT (DBS) TEST Launched December 2023 Launched March 2025 Simple finger prick performed in a physician’s office Platform used in Interstiti
Slide 42: Europe (EU4+UK) Market Development is Underway
Europe (EU4+UK) Market Development is Underway TREATMENT CENTER MAPPING1 Country Key Centers1 Est. TAM2 aPAP Centers of Excellence Germany 11 ~1,100 identified (8) UK 25 ~900 France 24 ~900 62 patients in Europe enrolled in IMPALA-2 trial Italy 16 ~700 open-label extension3 Spain 12 ~600 Total 8
Slide 43: MOLBREEVI: U.S. Commercial Opportunity
MOLBREEVI: U.S. Commercial Opportunity MOLBREEVI Clinically meaningful benefit Strong stakeholder interest Long Term Exclusivity Orphan drug pricing potential 12-year biologic exclusivity (U.S.) Chronic dosing Biosimilar competition unlikely Significant Unmet Need Efficient Rare Disease
Slide 44: Financials
Financials © Savara Inc. All Rights Reserved.
Slide 45: Financial Highlights
Cash runway into 2H 2027 • ~$172.5M in cash and short-term investments as of 3/31/25 • Non-dilutive debt financing for up to $200M* Strong investor support with coverage from 8 equity Financial research analysts Highlights ANALYST COVERAGE Jefferies Andrew Tsai Piper Sandler Yasmeen Rahimi, PhD
Slide 46: Near- and Long-Term U.S. Market Opportunity in aPAP is Sizeable
Near- and Long-Term U.S. Market Opportunity in aPAP is Sizeable ~3,600 Current U.S. TAM of identified aPAP patients $300K-$500K Orphan rare disease potential pricing power ~3,700 Large pool of likely patients that are currently undiagnosed Multiple Patents currently being prosecuted >$1B Potential 1
Slide 47: THANK YOU
THANK YOU © Savara Inc. All Rights Reserved.