Savara, Inc. · NASDAQ:SVRA
Savara — Mast Therapeutics — Merger or Acquisition (January 2017)
21 slides from Savara's merger presentation, Jan 9, 2017
Slide 1: Corporate presentation January 2017
Corporate presentation January 2017 Exhibit 99.2
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 in Brief
Savara in Brief Emerging Specialty Pharmaceutical Company Focused on Rare Respiratory Diseases Status: Private Founded:2008 Headquarters:Austin, TX Pipeline Pre-Clinical AeroVanc Cystic Fibrosis (CF) Pulmonary Alveolar Proteinosis (PAP) Indication Expansion Phase 1 Phase 2 Phase 3 Molgradex EU/Japan
Slide 4: 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 5: AeroVanc: Inhaled Vancomycin for MRSA in CF
AeroVanc Inhaled Vancomycin for MRSA in CF
Slide 6: Genetic Disease with Chronic Infections
Genetic Disease with Chronic Infections Source: Novartis and Gilead public filings. 2013 last year prior to generic entry 1990’s Tobramycin off-label use 2000 TOBI Acquired for $700M 2013 TOBI sales of $387M 2013 TOBI Podhaler Launch
Slide 7: Bacterial Infection Prevalence in CF
Bacterial Infection Prevalence in CF Source: 2015 CFF Patient Registry
Slide 8: Survival According to MRSA Status
Survival According to MRSA Status Dasenbrook, et al. reprinted with permission, Copyright © (2010) JAMA, All rights reserved.
Slide 9: Limited Treatment Options for MRSA
Limited Treatment Options for MRSA Exacerbations treated with IV vancomycin or linezolid Growing use of suppressive oral anti-MRSA antibiotics Systemic toxicities and poor lung penetration of IV abx Emerging use of nebulized IV form of vancomycin
Slide 10: AeroVanc: First Inhaled MRSA Antibiotic
AeroVanc: First Inhaled MRSA Antibiotic Strong Support from KOLs and CF Community Inhaled Dry Powder Vancomycin Drug Directly to Site of Infection Reduced Systemic Toxicity GSK as Commercial Manufacturer Orphan & QIDP status (12 years exclusivity)
Slide 11: Summary of AeroVanc Development
Efficacy PC / DB (n=200) Safety Open label (n=~150-170) Phase III* Summary of AeroVanc Development Proof of Concept PC / DB (n=87) Phase II Phase I Volunteers n=18 CF patients (n=7) Lung PK Preclinical Formulation Inhalation toxicology & safety pharmacology 2010 - 11 2011 - 12 2013 - 16 2017 - *Prop
Slide 12: FEV1 Improvement from baseline
FEV1 Improvement from baseline Per Protocol Population, 32 mg dose cohort, < 21 years of age, n = 16
Slide 13: Time to Use of Other Antibiotics
Time to Use of Other Antibiotics Intent-to-treat Population, 32 mg dose cohort, < 21 years of age, n = 20
Slide 14: Planned Phase III Study Design
PLANNED Phase III Study Design Screening Period BL n=100, Placebo n=100, AeroVanc Period 1- Double-blind W 8 W 12 W 24/BL W 16 W 20 W 4 N= up to 200, Open-label AeroVanc W 8 W 12 W 24 W 16 W 20 W 4 Period 2- Open-label Primary Endpoint FEV1 improvement across three cycles (absolute change) Secondary
Slide 15: Molgradex: Inhaled GM-CSF for PAP
Molgradex Inhaled GM-CSF for PAP
Slide 16: PAP Pathology
PAP Pathology Accumulation of surfactant in the alveoli Caused by auto-antibodies to GM-CSF Decreased gas exchange Shortness of breath/cough Prevalence (US) 2000-3000 patients Normal PAP
Slide 17: Prior Evidence for Inhaled GM-CSF
Prior Evidence for Inhaled GM-CSF Before After Tazawa et al. AJRCCM. 181:1345; 2010. Control GM-CSF Improvement in oxygen delivery (reduction in A-a oxygen gradient) mmHg
Slide 18: Molgradex: First Inhaled GM-CSF
Molgradex® – First Inhaled GM-CSF Novel Formulation of rhGM-CSF Direct delivery to the lungs to overcome functional deficiency Promising results in academically sponsored studies* PARI eFlow® nebulizer No approved drug treatments Orphan drug designation Tazawa et al. AJRCCM. 181:1345; 2010
Slide 19: Summary of Molgradex Development
USA FDA Dialogue ongoing Expand EU Study Endpoints TBD or Confirmatory Study Phase III Summary of Molgradex Development Europe & Japan N = 51 aPAP Change in AaDO2 Time to WLL ONGOING Data read 2018 Phase II/III Phase I N = 42 healthy vol SAD / MAD Well tolerated Potent PD Effect COMPLETE Preclinical
Slide 20: Design of Ongoing Phase II/III Study
Design OF Ongoing Phase II/III Study Screening Period 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, every other week dosing n=17, placebo W 72 *Physicians have the option to prescribe Open-label Molgradex 300µg, dosed daily, every o
Slide 21: Thank You!
THANK YOU!
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