Savara, Inc. · NASDAQ:SVRA
Savara — Investor Presentation (February 2018)
24 slides from Savara's investor presentation, Feb 12, 2018
Slide 1: Savara Corporate Presentation February 2018
Savara Corporate presentation (NASDAQ: SVRA) February 2018 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: Investment Highlights
Investment Highlights Pipeline Multiple late-stage assets addressing rare respiratory diseases Known treatment concepts – clinical risk reduction Over $1B peak sales potential* of two lead assets Near-term data readout and milestones Company World-class team with track record of developing respirato
Slide 4: Late-stage pipeline
Late-stage pipeline Pre-Clinical Molgradex* AeroVanc Aironite** Phase 1 Phase 2 Phase 3 * Serendex acquisition in July 2016 ** Mast acquisition in April 2017 Molgradex Pulmonary Alveolar Proteinosis (PAP) MRSA in Cystic Fibrosis (CF) Diastolic Heart Failure (HFpEF) Nontuberculous Mycobacteria (NTM)
Slide 5: Molgradex: Inhaled GM-CSF for Autoimmune Pulmonary Alveolar Proteinosis (aPAP)
Molgradex Inhaled GM-CSF for Autoimmune Pulmonary Alveolar Proteinosis (aPAP)
Slide 6: PAP: excess of surfactant in the lungs
PAP: excess of surfactant in the Lungs Anti-GM-CSF antibodies cause accumulation of surfactant in the alveoli Currently treated by whole lung lavage (WLL) Decreased oxygen delivery Hypoxia and shortness of breath US prevalence of ~2,500 patients* Typical onset 30-50 ys Mechanism of disease well unde
Slide 7: Inhaled GM-CSF promising in academic studies
Inhaled GM-CSF Promising in academic studies* aPAP patient before inhaled GM-CSF After 6 months of inhaled GM-CSF Improvement in alveolar to arterial oxygen gradient ((A-a)DO2) Published experience from treatment of more than 80 aPAP patients suggests potential for significant impact on oxygenation
Slide 8: Molgradex: First Inhaled GM-CSF
Molgradex: First Inhaled GM-CSF Inhalation solution of rhGM-CSF eFlow® Nebulizer (PARI Pharma)* Proprietary cell bank for GM-CSF manufacturing Orphan exclusivity (7 yrs US + 10 yrs EU) *investigational eFlow Nebulizer (PARI Pharma)
Slide 9: Phase 1 results: consistent WBC response to each dose
Phase 1 – consistent WBC response to each dose Safety in healthy volunteers comparable to placebo Potent dose-dependent pharmacodynamic effect
Slide 10: Design of ongoing IMPALA Phase 3 Study
Design OF Ongoing IMPALA Phase 3 Study Primary Endpoint Change from baseline in ((A-a)DO2) FDA to evaluate efficacy based on 3 alternative secondary endpoints adjusted for multiplicity Secondary Endpoints 6 min walk distance St. George’s respiratory questionnaire Requirement for/time to WLL Screenin
Slide 11: Molgradex: Inhaled GM-CSF for Nontuberculous Mycobacterial (NTM) Lung Infection
Molgradex Inhaled GM-CSF for Nontuberculous Mycobacterial (NTM) Lung Infection
Slide 12: The conundrum of NTM lung infection
The conundrum of NTM Lung INFECTiON Inability of macrophages to kill bacteria in the lungs Current antibiotic treatments toxic, burdensome and often inadequate Cough, fatigue, weight loss, progressive lung destruction US prevalence of up to 80,000 patients* Typical onset 50-75 yr Cell Death, Reseed
Slide 13: Emerging scientific support of GM-CSF for NTM
emerging Scientific support of GM-CSF for NTM* Inhaled INF-γ eradicated pulmonary M. abscessus Animal studies support key role of GM-CSF in chronic NTM lung infection Systemic GM-CSF explored in systemic NTM infection Inhaled GM-CSF eradicated / reduced M. abscessus** Candidate for Orphan & QIDP sta
Slide 14: Inhaled GM-CSF promising in pulmonary NTM
inhaled GM-CSF promising in pulmonary NTM* High positive smear and culture for M. abscessus Multi-drug antibiotics unsuccessful Dire clinical condition Inhaled GM-CSF for >1.5 years (first 3 mo with abx) Smear and culture negative (incl. BAL) Considerable clinical improvement High positive smear and
Slide 15: Molgradex Phase 2a open-label study in NTM
Molgradex Phase 2a OPEN-LABEL Study in NTM Primary Endpoint NTM sputum culture conversion to negative Secondary Endpoints NTM sputum smear conversion to negative Durability of NTM sputum conversion Reduction of NTM in sputum Change in 6 min walk distance Change in body weight Change in QoL and sympt
Slide 16: AeroVanc: Inhaled Vancomycin for MRSA in Cystic Fibrosis
AeroVanc Inhaled Vancomycin for MRSA in Cystic Fibrosis
Slide 17: High unmet need for inhaled MRSA treatment
HIGH UNMET NEED for INHALED MRSA Treatment Persistent lung infections managed with chronic inhaled antibiotics No approved inhaled MRSA antibiotic, emerging use of nebulized IV form of vancomycin MRSA infection associated with worse clinical outcomes CF Prevalence (US)* 30,000 patients, 26% MRSA inf
Slide 18: AeroVanc: First Inhaled MRSA Antibiotic
AeroVanc: First Inhaled MRSA Antibiotic Grants from CFF & NIH Inhaled Dry Powder Vancomycin Drug Directly to Site of Infection Designated Fast Track by the FDA Manufacturing at Commercial Scale Orphan 7 yrs + QIDP 5 yrs (total 12 years exclusivity)
Slide 19: FEV1 improvement consistent with TOBI data
FEV1 Improvement Consistent with TOBI Data PP population, 32 mg dose cohort, < 21 years of age, n = 16, post hoc analysis Best FEV1 improvement in young patients Similar FEV1 response profile in prior TOBI studies Absolute change in FEV1 selected as Phase 3 primary endpoint Phase 3 to be powered and
Slide 20: AVAIL Phase 3 study design
AVAIL Phase 3 STUDY design (per FDA guidance) Screening Period 1- Double-blind Period 2- Open-label BL Placebo, n = 100 AeroVanc 32mg, n = 100 W 8 W 12 W 24 W 16 W 20 W 4 AeroVanc 32mg, n = ~150-170 W 48 FEV 1 improvement (relative change, number of response cycles) FEV 1 improvement at Week 4 and W
Slide 21: Financials and Milestones
FINANCIALS AND MILESTONES
Slide 22: Savara Financial Overview
Savara FINANCIAL OVERVIEW Public follow-on offerings completed in Q2 & Q3/2017 ~$100 million total gross proceeds Cash as of September 30, 2017 ~$53.3 million Debt facility $15 million Common stock issued and outstanding as of November 8, 2017 30,500,693 Fully diluted capitalization as of November 8
Slide 23: Key Clinical Milestones
KEY CLINICAL MILESTONES H1 ‘18 H2 ‘18 H1 ‘19 H2 ‘19 Molgradex IMPALA Phase 3 Top Line Results Aironite Phase 2 INDIE Study Top Line Results AeroVanc AVAIL Phase 3 Study Top Line Results Molgradex IMPALA Phase 3 Study Enrollment Completes Molgradex Phase 2a NTM Study Initiation AeroVanc AVAIL Phase 3
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