Savara, Inc. · NASDAQ:SVRA

Savara — Investor Presentation (January 2025)

43 slides from Savara's investor presentation, January 2025

  1. Slide 1: Corporate Overview

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

  2. 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

  3. 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

  4. Slide 4: Autoimmune Pulmonary Alveolar Proteinosis (aPAP)

    Autoimmune Pulmonary Alveolar Proteinosis (aPAP) Overview and Burden of Disease

  5. 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

  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 aPAP, only treatment option is an invasive procedure Progressive Shortness of Breath  Gas exchange in the lungs is impaired and patients may experience shortness of breath Increased Risk of Infecti

  7. 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

  8. 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 visits +66% 3.5x (~17 per year) (CCI)* Vs. Vs. matched matched controls controls PAP: 1.84 ± 2.48 PAP: 17.30 ± 13.77 Age and Gender Matched Contr

  9. Slide 9: Patient Perspective on Living with aPAP

    Patient Perspective 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 t

  10. Slide 10: Disease Burden: Journey of an aPAP Patient

    Disease Burden: Journey of an aPAP Patient CURRENT JOURNEY POTENTIAL FUTURE JOURNEY Symptoms and Experience Diagnosis with aPAP Treatment Before Diagnosis 12 MONTHS 18 MONTHS aPAP ClearPath FROM FIRST EXPERIENCING AVERAGE TIME FROM FIRST SYMPTOMS TO SEEING A • Non-invasive, no-cost, simple SEEING A

  11. 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

  12. 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 •

  13. 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

  14. 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%

  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

  16. Slide 16: Demographics Were Well-Balanced Across Treatment Groups

    Demographics 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) 2 (2.4) Oth

  17. Slide 17: Primary Endpoint Met (DLCO): Achieved Statistical Significance

    Primary Endpoint Met (DLCO): Achieved Statistical Significance MOLBREEVI Superior to Placebo on Change From Baseline in DLCO at W24 (Primary Endpoint) and W48 (Secondary Endpoint) 15 15 p=0.0008 CFB (LS mean 95% CI) DLCO %Predadj 10 CFB (LS mean 95% CI) DLCO %Predadj 10 p=0.0007 5 5 0 0 0 4 8 12 16

  18. Slide 18: MOLBREEVI Superior to Placebo on SGRQ Total Score at W24

    MOLBREEVI Superior to Placebo on Change From Baseline in SGRQ Total Score at W24, Favorability Continues Through W48 0 0 CFB (LS mean 95% CI) CFB (LS mean 95% CI) SGRQ Total Score -5 SGRQ Total Score -5 -10 -10 p=0.0072 -15 -15 p=0.1046 -20 -20 0 4 8 12 16 20 24 28 32 36 40 44 48 24 48 24 48 24 48 W

  19. Slide 19: MOLBREEVI Nominally Significant on SGRQ Activity Score at W24

    MOLBREEVI Nominally Significant on Change From Baseline in SGRQ Activity Score at W24, Favorability Continues Through W48 0 0 SGRQ Activity Subscale CFB (LS mean, 95%CI) SGRQ Activity Subscale CFB (LS mean, 95%CI) -5 -5 -1 0 -10 -1 5 p=0.0149 -15 p=0.1216 -2 0 -20 2 4 4 8 2 4 4 8 2 4 4 8 0 4 8 12 16

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

    MOLBREEVI Nominally Significant on Change From Baseline in Exercise Capacity (Peak METs) at W48 2.0 2.0 1.5 CFB (LS mean, 95% CI) 1.5 p=0.0845 (LS Mean 95% CI) CFB Peak METS p=0.0234 1.0 Peak METs 1.0 0.5 0.5 0.0 0.0 -0.5 0 12 24 36 48 24 48 24 48 24 48 Weeks MOL Weeks PBO MOL PBO Difference in LS m

  21. Slide 21: Lung Lavage Was Permitted as a Rescue Therapy During the Trial

    Lung Lavage Was Permitted as a Rescue Therapy During the Trial During 48-week double-blind period • 17 (~10%) patients underwent at least one lung lavage — MOLBREEVI: n=6 (7.4%) — Placebo: n=11 (13.3%) © Savara Inc. All Rights Reserved. 21

  22. Slide 22: 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

  23. Slide 23: 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)

  24. Slide 24: Overview of IMPALA-2 Results: Top Line, DSS, Responder Analyses, and 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

  25. Slide 25: Regulatory and Intellectual Property

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

  26. Slide 26: 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 Rolling Complete BLA Rolling Filing Potential Approval* Submission Submission EU EU MAA Potential Approval Submission *Assumes Priority Review is granted by the FDA © Savara Inc. All Rights Re

  27. Slide 27: Regulatory and IP Summary

    MOLBREEVI IN aPAP REGULATORY DESIGNATIONS Regulatory and IP   Orphan Drug Designation, Europe (eligible for 10 years exclusivity) Orphan Drug Designation, U.S. (eligible for 7 years exclusivity) Summary  Fast Track Designation, U.S.  Breakthrough Therapy Designation, U.S.  Innovation Passport D

  28. Slide 28: Commercial Update

    Commercial Update © Savara Inc. All Rights Reserved.

  29. Slide 29: 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 Evolve antibody of autoimmune PAP Hire and onboard key capabilities to facilitate testing platform with among targeted commercial roles to access to an

  30. Slide 30: 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 Advocacy Social Media Paid Media Conferences Tele-Educators DSA Brochure 3rd Party Email Paid Media TV/YouTube The Balancing Act © Savara Inc. All R

  31. Slide 31: 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

  32. Slide 32: 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

  33. Slide 33: Significant U.S. Opportunity with ~3,600 Currently Diagnosed aPAP Patients

    Significant U.S. Opportunity with ~3,600 Currently Diagnosed aPAP Patients CONFIRMED DIAGNOSED aPAP PATIENTS1 UNCONFIRMED HIGHLY LIKELY AND LIKELY aPAP1 ~3,600 (U.S. Claims Data Analysis) +1,400 Highly likely +2,300 Likely Analysis of comprehensive claims dataset  Counted PAP ICD9/10 diagnosis code

  34. Slide 34: U.S. Centers Prioritized Based on Experience Treating aPAP Patients

    U.S. Centers Prioritized Based on Experience Treating aPAP Patients GOAL: Line of Sight to 1,000 Patients at Launch U.S. PATIENTS / HCP HEATMAP1 COEs† Currently have line of sight to ~450 patients ILD Centers*  Confirmed Location  Treating Physician  Patient Management General Pulmonary Centers 1

  35. Slide 35: 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

  36. Slide 36: Claims Data Analysis Suggests U.S. Market May Be 2x Larger

    Claims Data Analysis Suggests U.S. Market May Be 2x Larger CONFIRMED DIAGNOSED aPAP PATIENTS1 UNCONFIRMED HIGHLY LIKELY AND LIKELY aPAP1 ~3,600 (U.S. Claims Data Analysis) +1,400 Highly likely +2,300 Likely Analysis of comprehensive claims dataset  Counted PAP ICD9/10 diagnosis codes from 300M+ liv

  37. Slide 37: aPAP ClearPath Testing Platform

    aPAP ClearPath Testing Platform No cost antibody testing to identify aPAP among undiagnosed patients CURRENTLY AVAILABLE: SERUM COMING SOON: DRIED BLOOD SPOT (DBS)  Simple finger prick performed in a physician’s office  Removes logistical challenges to serum testing  Target launch end of 1Q 2025

  38. Slide 38: 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  aPAP ClearPath antibody France 24 ~900 test launched in Europe Italy 16 ~700  62 patients in Europe Spain 12 ~600 enroll

  39. Slide 39: 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

  40. Slide 40: Financials

    Financials © Savara Inc. All Rights Reserved.

  41. Slide 41: Financial Highlights

     Cash runway through 2Q 2027 • ~$219M in cash, cash equivalents and short-term investments*  Strong investor support with coverage from 8 equity research analysts Financial Highlights ANALYST COVERAGE Jefferies Andrew Tsai Piper Sandler Yasmeen Rahimi, PhD Guggenheim Securities Vamil Divan, MD, MB

  42. Slide 42: 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 confirmed diagnosed 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 Potenti

  43. Slide 43: Thank You

    THANK YOU © Savara Inc. All Rights Reserved.

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