Savara, Inc. · NASDAQ:SVRA
Savara — Mast Therapeutics — Merger or Acquisition (March 2017)
26 slides from Savara's merger presentation, Mar 6, 2017
Slide 1: Corporate presentation March 2017
Corporate presentation March 2017 Exhibit 99.1
Slide 2: Safe Harbor Statements
Safe Harbor Statements Forward Looking Statements. Savara 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 “will,
Slide 3: Savara Overview
Savara Overview Clinical Stage Specialty Pharmaceutical Company… …Focused on Rare Respiratory Diseases Late-stage products Growth through pipeline expansion Reverse merger with NYSE MKT:MSTX pending Pre-Clinical AeroVanc Cystic Fibrosis (CF) Pulmonary Alveolar Proteinosis (PAP) Undisclosed Lung Infe
Slide 4: MAST Merger Underway
MAST Merger Underway Merger announced in Jan 2017 Pending Mast and Savara shareholder consent Name change to Savara Inc. Ticker symbol change to SVRA Merger anticipated closing Q2 2017 Expected Ownership post-merger* Proforma Market Cap at $0.13 SP Savara 76 % $140M Mast Therapeutics 24 % *Subject t
Slide 5: AeroVanc Inhaled Vancomycin for MRSA in CF
AeroVanc Inhaled Vancomycin for MRSA in CF
Slide 6: CF: Genetic disease with Chronic Infections
CF: Genetic disease with Chronic Infections Inhaled anti-pseudomonal antibiotic market (TOBI & Cayston) reached ~$500 million* Genetic disease with thick, sticky mucus in the lung Inhaled antibiotics established as routine infection management Persistent lung infections leading to lung damage, trans
Slide 7: High Unmet Need for Inhaled MRSA Treatment
HIGH UNMET NEED for INHALED MRSA Treatment Prevalence of MRSA increasing MRSA lung infection in CF associated with worse clinical outcomes No approved inhaled antibiotics active against MRSA Clinicians indicate high unmet need, and high utilization rates1 Source: 2015 CFF Patient Registry Dasenbrook
Slide 8: Limited Treatment Options for MRSA in CF
Limited Treatment Options for MRSA in CF High antibiotic concentrations in the lung required in CF No approved inhaled options for MRSA Exacerbations treated with IV vancomycin or linezolid Growing use of suppressive oral anti-MRSA antibiotics Emerging use of nebulized IV form of vancomycin
Slide 9: AeroVanc: First Inhaled MRSA Antibiotic
AeroVanc: First Inhaled MRSA Antibiotic Grants from CFF & NIH Inhaled Dry Powder Vancomycin Drug Directly to Site of Infection Reduced Systemic Toxicity Manufacturing at Commercial Scale Orphan & QIDP status (12 years exclusivity)
Slide 10: AeroVanc Development Path: Phase III Ready
Pivotal PC / DB (n=200) Enrollment anticipated to begin in Q3 2017 Phase III* (Planned) AeroVanc Phase III ready Proof of Concept PC / DB (n=87) Primary endpoint met; encouraging trends in lung function, time to antibiotics Phase II (Complete) Phase I (Complete) Volunteers (n=18) CF patients (n=7) G
Slide 11: Phase II: MRSA in Sputum - Primary Endpoint Met
Phase II: MRSA in Sputum - Primary Endpoint Met ITT population, n = 87 patients Proof of concept established Microbiology not acceptable to FDA as Phase III primary endpoint
Slide 12: Dose Selected for Phase III Study
32 mg Dose Selected for Phase III Study Vancomycin trough concentrations in high excess over MIC at both doses ~ 50 % premature study drug discontinuations at 64 mg dose PK Population, AeroVanc treatments only, n=11
Slide 13: 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 In TOBI trials, best FEV1 improvement in young patients Similar FEV1 response profile with AeroVanc, study not powered for secondary endpoints Absolute change in FEV1 selected as
Slide 14: Improvement in Time to Other Antibiotics
Improvement in Time to other antibiotics ITT, 32 mg dose cohort, < 21 years of age, n = 20 , post hoc analysis Prolongation of time to use of other antibiotics In chronic use, a new treatment cycle would start at day 56, and events (use of other antibiotics) would not be expected at that time Time t
Slide 15: Phase III Design Agreed with FDA
Phase III design agreed with FDA Screening Period 1- Double-blind Period 2- Open-label BL Placebo, n = 100 AeroVanc, n = 100 W 8 W 12 W 24 W 16 W 20 W 4 AeroVanc, n = ~150-170 W 48 FEV 1 improvement (relative change, number of response cycles) FEV 1 improvement at Week 4 and Week 20 (absolute change
Slide 16: Molgradex Inhaled GM-CSF for aPAP
Molgradex Inhaled GM-CSF for Autoimmune Pulmonary Alveolar Proteinosis (aPAP)
Slide 17: 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 2000-3000 patients Mechanism of disease well understood
Slide 18: 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 profound impact on oxygenation and
Slide 19: Molgradex: First Inhaled GM-CSF
Molgradex: First Inhaled GM-CSF Direct lung delivery to overcome functional GM-CSF deficiency Inhalation solution of rhGM-CSF PARI eFlow® Nebulizer No approved drug treatments Considerable indication extension opportunity Orphan status (7-10 years exclusivity)
Slide 20: FDA Dialogue Ongoing
FDA Dialogue Ongoing Expand PII/III study with alternative endpoints or Confirmatory study Phase III* (Planned) Molgradex: PIVOTAL study for Europe Enrolling Pivotal EU & Japan (n=51 aPAP) Data read Q1/2018 Change in AaDO2 Time to WLL Phase II/III (Ongoing) Phase I (Complete) Volunteers (n=42) SAD /
Slide 21: Phase I – Consistent WBC Response to Each Dose
Phase I – consistent WBC response to each dose Safety in healthy volunteers comparable to placebo Potent dose-dependent pharmacodynamic effect
Slide 22: Design of Ongoing Molgradex Phase II/III Study
Design OF Ongoing Molgradex Phase II/III Study Screening BL n=17, 300µg, daily dosing Period 1- Double-blind W 8 W 12 W 24 W 16 W 20 W 4 Period 2- Follow-up* n=17, 300µg, daily dosing every other week n=17, placebo W 72 *Option to prescribe open-label Molgradex, every other week dosing Primary Endpo
Slide 23: Anticipated Corporate Milestones
Anticipated Corporate milestones Q2 ‘17 Q3 ‘17 Q4 ‘17 Q1 ‘18 Q1 ‘17 Q2 ‘18 Merger with Mast Announced AeroVanc Phase III Enrollment to Start Molgradex Top Line Results from Phase II/III Study Merger with Mast to Close Molgradex US Study Design to be Announced AIR001 Top Line Results from INDIE HFpEF
Slide 24: Investment Highlights
Investment Highlights Pipeline Multiple late-stage assets addressing orphan diseases Previously approved active drug substances and drug delivery technologies High local drug concentrations reducing systemic toxicity Strong market protection Strategy Pursue AeroVanc and Molgradex indication expansio
Slide 25: Management & Advisors
Management & Advisors Executive Team Rob Neville, CEO Serial entrepreneur / Evity exit $100M / Series A lead investor Dr. Taneli Jouhikainen, COO Serial drug developer / 10+ license deals / public company and IPO experience / 20 yrs. in pharma mgmt. David Lowrance, CPA 15 years biotech / pharma, pub
Slide 26: Thank You!
THANK YOU!
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