Savara, Inc. · NASDAQ:SVRA
Savara — Investor Presentation (January 2021)
17 slides from Savara's investor presentation, Jan 19, 2021
Slide 1: Savara Corporate Presentation
Savara Corporate Presentation (NASDAQ: SVRA) January 2021 Exhibit 99.1
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: A Clinical-Stage Orphan Lung Disease Company Based in Austin and Copenhagen
A Clinical-Stage Orphan Lung Disease Company Based in Austin and Copenhagen Developing new medicines for rare lung diseases. To become THE orphan lung disease company. Company leaders are experts in their field. Focused Therapeutic Area Clear Vision Strong Management Team ~ $82M* Cash, cash equivale
Slide 4: Executive Leadership
Executive Leadership We are a team with deep expertise in orphan lung diseases and pulmonary medicine and a proven track record that spans from early clinical development through commercialization. Matthew Pauls Chairman and CEO Dave Lowrance CFO Badrul Chowdhury CMO
Slide 5: Molgradex: Molgramostim Inhalation Solution for aPAP
Molgradex Molgramostim Inhalation Solution for Autoimmune Pulmonary Alveolar Proteinosis (aPAP)
Slide 6: APAP: Excess of Surfactant in the Lungs
APAP: Excess of Surfactant in the Lungs Mechanism of disease well understood *Trapnell BC, et. al. Am J Respir Crit Care Med. 2014 US prevalence of ~2,500 patients* Typical onset 30-50 yrs Anti-GM-CSF antibodies cause accumulation of surfactant in the alveoli Decreased oxygen delivery Hypoxia and sh
Slide 7: IMPALA Study Did Not Meet Primary Endpoint
IMPALA Study Did Not Meet Primary Endpoint *Full Analysis Set (FAS) Estimated treatment difference of -4.6 mmHg (p=0.17) †Revised FAS Estimated treatment difference of -6.5 mmHG (p=0.025) CONTINUOUS DOSE (OD) IMPALA was conducted at 34 sites across 18 countries. *Protocol specified analysis (ITT). †
Slide 8: IMPALA: DLCO and SGRQ Showed Robust Improvement with Continuous Dose
IMPALA: DLCO and SGRQ Showed Robust Improvement with Continuous Dose (OD) OD estimated treatment difference of 7.9% predicted (p=0.007) Change in Diffusion Capacity for Carbon Monoxide (DLCO) From Baseline Over 24-weeks (FAS) Change in St. George’s Respiratory Questionnaire (SGRQ) From Baseline Over
Slide 9: IMPALA Open-Label Data Show Sustained Effect After Longer-Term Exposure
IMPALA Open-Label Data Show Sustained Effect, or Continued Improvement, after Longer-Term Drug Exposure Continuous Molgradex Placebo Intermittent Molgradex Dosing schedules for blinded and open-label period were different. Mean Change in DLCO Over Time n=44 n=46 n=43 n=42 n=40 n=41 n=19 n=18 All pat
Slide 10: IMPALA Study Results Published in NEJM in September 2020
Published online on 9/2/2020. IMPALA Study Results Published in NEJM in September 2020 IMPALA Study Results Published in NEJM in Sept. 2020
Slide 11: IMPALA 2 Study Design
IMPALA 2 Study Design SGRQ Total Score SGRQ Activity Score Exercise capacity using treadmill test Change from baseline in DLCO 90% powered to detect 5.7% predicted difference with standard deviation of 11 = Primary efficacy analyses = Durability of efficacy / safety Secondary Endpoints Primary Endpo
Slide 12: Clinical Trial Design: IMPALA vs. IMPALA 2
Clinical Trial Design: IMPALA vs. IMPALA 2 IMPALA IMPALA 2 Primary endpoint: Gas Exchange: A-aDO2 (surrogate endpoint) Secondary endpoints: SGRQ Total (direct patient benefit)6-minute walk distance Whole lung lavage Device: Pari eFlow Nebulizer System Number of study sites: 34 Geographies: 18 countr
Slide 13: AeroVanc: Inhaled Vancomycin for MRSA in Cystic Fibrosis
AEROVANC Inhaled Vancomycin for MRSA in Cystic Fibrosis
Slide 14: Phase 3 AVAIL Study Did Not Meet Primary Endpoint, Discontinuing AeroVanc
Phase 3 AVAIL Study Did Not Meet Primary Endpoint, Discontinuing Development of AeroVanc Mean change from baseline in FEV1 percent predicted compared to placebo: Week 4: 1.4 (p=0.33) Week 12: 1.3 (p=0.33) Week 20: 3.0 (p=0.07) Exacerbation rate per year = 2.3 for both groups (risk ratio 1.0, 95% CI
Slide 15: Financials and Milestones
Financials and Milestones
Slide 16: Savara Financial Overview
Savara Financial Overview *Includes first tranche ($26.8M gross) from 12/19 financing. This is an unaudited estimation as of 12/10/20. The Company is still in the process of determining final results for Q4 2020. . Cash, cash equivalents, and short-term investment securities ~$82 million* Loan and s
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