Savara, Inc. · NASDAQ:SVRA

Savara — Investor Presentation (September 2025)

48 slides from Savara's investor presentation, Sep 2, 2025

  1. Slide 1: Corporate Overview: Developing New Therapies for Rare Respiratory Diseases

    Corporate Overview Developing New Therapies for Rare Respiratory Diseases September 2025 © Savara Inc. All Rights Reserved. Exhibit 99.1

  2. Slide 2: Safe Harbor Statement

    Safe Harbor Statement © Savara Inc. All Rights Reserved. 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,” “pla

  3. Slide 3: Executive Leadership Team

    Executive Leadership Team © Savara Inc. All Rights Reserved. 1zxza Matthew Pauls, J.D., M.B.A. Chair & Chief Executive Officer Anne Erickson Chief Business Officer Dave Lowrance Chief Financial & Administrative Officer Rob Lutz, M.B.A. Chief Operating Officer Braden Parker, M.B.A. Chief Commercial O

  4. Slide 4: Autoimmune PAP Overview and Burden of Disease

    Autoimmune Pulmonary Alveolar Proteinosis (autoimmune PAP) Overview and Burden of Disease © Savara Inc. All Rights Reserved.

  5. Slide 5: Autoimmune PAP: Disease of Alveolar Macrophage Dysfunction

    Autoimmune PAP: Disease of Alveolar Macrophage Dysfunction © Savara Inc. All Rights Reserved. Alveoli need surfactant to keep from collapsing GM-CSF is critical for alveolar macrophage function and allows for alveolar surfactant homeostasis, structure, function, and host defense NORMAL vs ABNORMAL A

  6. 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 autoimmune PAP, only treatment option is an invasive procedure © Savara Inc. All Rights Reserved. Progressive Shortness of Breath With impaired gas exchange, patients may experience shortness of bre

  7. Slide 7: Lung Lavage is an Invasive Procedure

    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 becomes clear A L

  8. Slide 8: Disease Burden: Higher Healthcare Utilization and Comorbidities

    © 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 hosp

  9. Slide 9: Patient Perspectives on Living with Autoimmune PAP

    Patient Perspectives on Living with Autoimmune PAP © Savara Inc. All Rights Reserved. TO HEAR THESE PATIENTS' STORIES, PLEASE VISIT WWW.SAVARAPHARMA.COM 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 yo

  10. Slide 10: Disease Burden: Journey of an Autoimmune PAP Patient

    Disease Burden: Journey of an Autoimmune PAP Patient1 © Savara Inc. All Rights Reserved. MOLBREEVI* Clinically meaningful positive Phase 3 results that suggest MOLBREEVI may address the pathophysiology of autoimmune PAP Favorable benefit/risk profile Well tolerated Dec. 2025: Plan to resubmit BLA Sy

  11. Slide 11: MOLBREEVI (molgramostim inhalation solution)

    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)

  12. Slide 12: Investigational Drug-Device Treatment for Autoimmune PAP

    © Savara Inc. All Rights Reserved. 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 5 FDA approved nebulizers based on eFlow® Technology Savara

  13. Slide 13: Summary of IMPALA-2 Results

    Summary of IMPALA-2 Results © Savara Inc. All Rights Reserved. DLco%, hemoglobin-adjusted percent predicted diffusing capacity of the lungs for carbon monoxide; SGRQ, St. Georges Respiratory Questionnaire. 1Statistically significant.2Nominally significant. Change from baseline to Week 24 in DLco% (p

  14. Slide 14: Phase 3 IMPALA-2 Trial Design

    Phase 3 IMPALA-2 Trial Design © Savara Inc. All Rights Reserved. PRIMARY ENDPOINT Change from baseline in DLCO at W24 6-Week Screening Period 1: Double-blind (top line) Period 2: Open-label (ongoing, not part of top line results) SECONDARY ENDPOINTS Change from baseline in: DLCO at W48 SGRQ Total Sc

  15. Slide 15: Low Discontinuations and High Open Label Participation

    Discontinuations in Double-Blind Period Were Low: 3% Participation in Open Label Period Was High: 100% of Double-Blind Period Completers © Savara Inc. All Rights Reserved. Screened (n=286) Randomized (n=164) MOLBREEVI n=81 Placebo n=83 Ineligible Patients (n=122) Week 48 Completers n=79 (97.5%) Week

  16. Slide 16: Demographics in IMPALA-2 Were Well-Balanced

    Demographics in IMPALA-2 Were Well-Balanced Across Treatment Groups © Savara Inc. All Rights Reserved. MOLBREEVI N=81 Placebo N=83 Age years Mean (SD) 50.8 (13.03) 48.4 (12.69) Sex n (%) Male Female 44 (54.3) 37 (45.7) 54 (65.1) 29 (34.9) Race n (%) White Asian Black or African American Other 38 (46

  17. Slide 17: MOLBREEVI Superior to Placebo on DLCO at W24 and W48

    IMPALA-2: MOLBREEVI Superior to PBO on Change from Baseline in DLCO at W24 (primary endpoint) and W48 (secondary endpoint) © Savara Inc. All Rights Reserved. The minimal clinically important difference (MCID) in change in DLCO is 10% in progressive pulmonary fibrosis and 11% in severe COPD.1 MOLBREE

  18. 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 © Savara Inc. All Rights Reserved. LSM Change from Baseline Between-Group LSM Difference* P-value Week 24 Mol: -11.5 Pbo: -4.9 -6.59 0.0072† Week 48 Mol: -10.7 Pbo: -5.9 -4.87 0

  19. Slide 19: 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 © Savara Inc. All Rights Reserved. *Mean change from baseline compared with placebo. P-values are for difference in LSM compared with placebo. †P-value nominally signif

  20. Slide 20: Nominally Significant on Exercise Capacity at W48

    IMPALA-2: MOLBREEVI Nominally Significant on Change From Baseline in Exercise Capacity (Peak METs) at W48 © Savara Inc. All Rights Reserved. *Mean change from baseline compared with placebo. P-values are for difference in LSM compared with placebo. †P-value nominally significant: P-value ≤0.05 but d

  21. Slide 21: MOLBREEVI Reduces Pulmonary Surfactant Burden: GGO Score

    IMPALA-2 Demonstrated That MOLBREEVI Reduces Pulmonary Surfactant Burden: Ground Glass Opacity Score at W24 © Savara Inc. All Rights Reserved. *P-value based on post-hoc analysis. GGO, ground glass opacity. MOLBREEVI (N=78) Placebo (N=79) p=0.0004* Baseline After 24 weeks on MOLBREEVI

  22. Slide 22: Whole Lung Lavage Permitted as Rescue Therapy

    Whole Lung Lavage (WLL) was Permitted as a Rescue Therapy During the IMPALA-2 Trial © Savara Inc. All Rights Reserved. 17 (~10%) patients underwent at least one lung lavage

  23. Slide 23: IMPALA-2 Safety Summary: Well-Tolerated

    IMPALA-2 Safety Summary: MOLBREEVI Was Well-Tolerated © Savara Inc. All Rights Reserved. Treatment Emergent Adverse Events MOLBREEVI N=81 n (%) Placebo N=83 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

  24. Slide 24: IMPALA-2 Safety Summary: Most Common Adverse Events

    IMPALA-2 Safety Summary: Most Common Adverse Events © Savara Inc. All Rights Reserved. ADVERSE EVENTS IN >10% OF PATIENTS IN ANY TREATMENT ARM DURING DOUBLE-BLIND TREATMENT PERIOD Treatment Emergent Adverse Events MOLBREEVI (N=81) n (%) Placebo (N=83) n (%) Any 69 (85) 71 (86) Most common COVID-19 1

  25. Slide 25: Overview of IMPALA-2 Results

    Overview of IMPALA-2 Results: Top Line, DSS, Responder Analyses, and GGO Data © Savara Inc. All Rights Reserved. Measure Timeframe P-Value / Results Pulmonary gas exchange DLCO% Week 24 Week 48 0.0007 0.0008 Disease Severity Score (DSS) Responder Analysis - DLco% Week 24 Week 48 Weeks 24 and 48 0.02

  26. Slide 26: Results Published in the New England Journal of Medicine

    Results from IMPALA and IMPALA-2 Clinical Trials Were Published in the New England Journal of Medicine © Savara Inc. All Rights Reserved. Published online on 9/2/2020. Published online on 8/21/2025. IMPALA RESULTS IMPALA 2 RESULTS

  27. Slide 27: Real-World Retrospective Outcomes Data

    Real-World, Retrospective Outcomes Data Suggest MOLBREEVI Addresses Underlying Pathophysiology of Autoimmune PAP Case Series Evaluated 5 aPAP Patients Who Received MOLBREEVI Through Single Patient Access © Savara Inc. All Rights Reserved. Montaño C, Bendstrup E, Rønnov-Jessen I, et al. ERJ Open Res

  28. Slide 28: Regulatory and Intellectual Property

    Regulatory and Intellectual Property © Savara Inc. All Rights Reserved.

  29. Slide 29: Planned U.S. and European Regulatory Timeline

    Planned U.S. and European Regulatory Timeline US Started BLA Rolling Submission EU Completed BLALA Submission BLA Resubmission with Fuji as DS Manufacturer Potential Approval* MAA Submission Potential Approval © Savara Inc. All Rights Reserved. *Assumes Priority Review is granted by the FDA UK MAA S

  30. Slide 30: MOLBREEVI Regulatory and IP Summary

    MOLBREEVI in Autoimmune PAP Regulatory and IP Summary © Savara Inc. All Rights Reserved. Upon Biologics License Application (BLA) approval FDA would grant 12 years marketing exclusivity BIOLOGIC EXCLUSIVITY US Orphan Drug Designation (eligible for 7 years exclusivity) Fast Track Designation Breakthr

  31. Slide 31: Commercial Update

    Commercial Update © Savara Inc. All Rights Reserved.

  32. Slide 32: Commercial Launch Planning Advancing Against Near-Term Objectives

    Commercial Launch Planning Advancing Against Near-Term Objectives © Savara Inc. All Rights Reserved. Expand awareness of autoimmune PAP and educate on the importance of early testing Build critical capabilities to facilitate access to MOLBREEVI post approval Hire and onboard key commercial roles to

  33. Slide 33: Autoimmune PAP Disease State Awareness Campaign

    Autoimmune PAP Disease State Awareness Campaign Multi-channel effort across healthcare professionals (HCP) and patients © Savara Inc. All Rights Reserved. HCP DSA Campaign Patient DSA Campaign

  34. Slide 34: aPAP ClearPath: No Charge Testing Program

    aPAP ClearPath: No Charge Third-Party Testing Program in the U.S.* © Savara Inc. All Rights Reserved. Launched March 2025 Simple finger prick performed in a physician’s office Removes logistical challenges to serum testing ILD program to be expanded, leveraging DBS test** SERUM TEST Launched Decembe

  35. Slide 35: 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 © Savara Inc. All Rights Reserved. Single source pharmacy will service all patients with direct shipments and ongoing support Smaller patient population is best served by

  36. Slide 36: MyMolbreevi Support Program in Development

    MyMolbreevi: Best in Class Support Program in Development Program aims to reduce access barriers for appropriate MOLBREEVI patients post approval © Savara Inc. All Rights Reserved. Clinical education Pharmacist calls Device training Nurse educators Adherence support Financial assistance Commercial c

  37. Slide 37: Overwhelming Support for MOLBREEVI Across Stakeholders

    Overwhelming Support for MOLBREEVI Across Stakeholders © Savara Inc. All Rights Reserved. U.S. PATIENTS U.S. PULMONOLOGISTS 83% Likely to prescribe MOLBREEVI regardless of severity of disease Perceived MOLBREEVI as superior to current options based on: Overall efficacy Simple, standard nebulizer Fav

  38. Slide 38: Market Development Team

    Market Development Team Broadens market reach and accelerates pre-launch activities © Savara Inc. All Rights Reserved. Projected market development team of ~25 people (including leadership) Target list of accounts expanded beyond current field medical list to broaden reach Territory managers will be

  39. Slide 39: Studies on Autoimmune PAP Epidemiology

    Studies on Autoimmune PAP Epidemiology Range From 6-26 Patients P/Million © Savara Inc. All Rights Reserved. REFERENCE METHODOLOGY INCIDENCE PER MILLION DIAGNOSED PREVALENCE PER MILLION DIAGNOSED PREVALENCE Inoue 2008 Registry based in Niigata, Japan 0.48 (0.23-1.00) 6.2 (3.8-10.3) McCarthy 2018 US

  40. Slide 40: 2025 U.S. Claims Data: Market ~50% Larger

    2025 U.S. Claims Data Analysis Indicates Autoimmune PAP Market is ~50% Larger than Previously Projected © Savara Inc. All Rights Reserved. * Reporting Period 2008-2023; Patient Stabilization Period (3/1/2021 - 2/28/2023), projected ** Reporting Period: 2017-2025; Patient Stabilization Period (1/1/20

  41. Slide 41: Claims Data Sources Account for Increase in Patients

    More Comprehensive Data Source, Larger Number of Records, and Newer Claims Account for Increase in Patients © Savara Inc. All Rights Reserved. 2025 U.S. CLAIMS DATA ANALYSIS (Second Source Dataset) 2023 U.S. CLAIMS DATA ANALYSIS ~3,600 ~5,500 Coverage: ~300M lives Dataset: Open-source Data capture:

  42. Slide 42: U.S. Centers Prioritized Based on Autoimmune PAP Experience

    U.S. Centers Prioritized Based on Autoimmune PAP Experience Goal: Line of Sight to 1,000 Patients at Launch to Maximize Early Launch Phase © Savara Inc. All Rights Reserved. COEs† ILD Centers* General Pulmonary Centers U.S. PATIENTS / HCP HEAT MAP1 1 Data from 2023 U.S. Insurance Claims Analysis con

  43. Slide 43: Europe (EU4+UK) Market Development is Underway

    Europe (EU4+UK) Market Development is Underway 43 © Savara Inc. All Rights Reserved. TREATMENT CENTER MAPPING1 Country Key Centers1 Est. TAM2 Germany 11 ~1,300 UK 25 ~1,104 France 24 ~1,104 Italy 16 ~944 Spain 12 ~784 Total 88 ~5,200 1 Savara 2024 EU4+ UK Primary (N= 6 EU4+ UK Principal Investigator

  44. Slide 44: MOLBREEVI: U.S. Commercial Opportunity

    MOLBREEVI: U.S. Commercial Opportunity © Savara Inc. All Rights Reserved. MOLBREEVI Clinically meaningful benefit Strong stakeholder interest Orphan drug pricing potential Chronic dosing Small customer facing footprint Exclusive pharmacy network 12-year biologic exclusivity (U.S.) Biosimilar competi

  45. Slide 45: Financials

    Financials © Savara Inc. All Rights Reserved.

  46. Slide 46: Financial Highlights

    Financial Highlights © Savara Inc. All Rights Reserved. Cash runway into 1Q 2027 ~$146M in cash and short-term investments as of 6/30/25 Strong investor support with coverage from 7 equity research analysts ANALYST COVERAGE Jefferies Andrew Tsai Piper Sandler Yasmeen Rahimi, PhD Guggenheim Securitie

  47. Slide 47: Near- and Long-Term U.S. Market Opportunity in Autoimmune PAP

    Near- and Long-Term U.S. Market Opportunity in Autoimmune PAP is Sizeable © Savara Inc. All Rights Reserved. Current U.S. TAM of autoimmune PAP patients >$2B Potential U.S. Opportunity $400K-$500K ~5,500 Orphan rare disease potential pricing power Patents currently being prosecuted Multiple Biologic

  48. Slide 48: Thank You

    THANK YOU © Savara Inc. All Rights Reserved.

Savara — Investor Presentation (September 2025) on 6ix