Savara, Inc. · NASDAQ:SVRA
Savara — Investor Presentation (March 2021)
18 slides from Savara's investor presentation, Mar 16, 2021
Slide 1: Savara Corporate Presentation
Savara Corporate Presentation (NASDAQ: SVRA) March 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: Savara: A Clinical-Stage Orphan Lung Disease Company
Savara: A Clinical-Stage Orphan Lung Disease Company Based in Austin and Copenhagen Developing new therapeutics 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
Slide 4: Transformational Evolution of Savara
Transformational Evolution of Savara 2019 2020 2021 - 2024 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Trial did not meet its primary endpoint of alveolar-arterial oxygen gradient (A-aDO2) Improvements in SGRQ suggest molgramostim nebulizer solution* may improve health status in patients with autoimmune pul
Slide 5: 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 Chief Executive Officer Dr. Badrul Chowdhury Chief Medical Officer Dave Low
Slide 6: Molgramostim for Autoimmune Pulmonary Alveolar Proteinosis (aPAP)
Molgramostim for Autoimmune Pulmonary Alveolar Proteinosis (aPAP) Molgramostim
Slide 7: aPAP: A Disease of Alveolar Macrophage Dysfunction
aPAP: A Disease of Alveolar Macrophage Dysfunction Alveolar macrophages Need GM-CSF for maturation, expansion, and function (e.g., surfactant clearance) GM-CSF Critical to alveolar homeostasis, structure, function, and host defense aPAP Caused by GM-CSF autoantibodies which block GM-CSF signaling an
Slide 8: IMPALA Trial Design
IMPALA Trial Design Secondary Endpoints** 6-minute walk distance St. George’s respiratory questionnaire Time to WLL/requirement for WLL **Secondary endpoints: Analyzed in parallel and corrected for multiplicity Primary Endpoint* Change from baseline in A-aDO2 *Primary analysis: Continuous dose vs. p
Slide 9: IMPALA Trial Results Published in New England Journal of Medicine
Published online on 9/2/2020. IMPALA Trial Results Published in New England Journal of Medicine in September 2020
Slide 10: IMPALA Trial Did Not Meet Primary Endpoint
IMPALA Trial 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 ONCE DAILY DOSING REGIMEN (OD) *Protocol specified analysis (ITT). †Revised analysis excludes 4 patie
Slide 11: IMPALA: DLCO and SGRQ Showed Robust Improvement with Continuous Once Daily Dosing
IMPALA: DLCO and SGRQ Showed Robust Improvement with Continuous Once Daily Dosing Regimen (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 (SGR
Slide 12: IMPALA Open-Label Data Show Sustained Effect
IMPALA Open-Label Data Show Sustained Effect, or Continued Improvement, after Longer-Term Drug Exposure Continuous molgramostim Placebo Intermittent molgramostim Dosing schedules for blinded and open-label periods were different. All patients received intermittent molgramostim during open-label peri
Slide 13: IMPALA 2 Trial Design Leverages Key Learnings from IMPALA
IMPALA 2 Trial Design Leverages Key Learnings from IMPALA 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 / safe
Slide 14: 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 e-Flow Nebulizer System Number of trial sites:34 Geographies: 18 countri
Slide 15: IMPALA 2 Timelines
Activity Date Start of patient randomization 2Q 2021 Top line data readout from double-blind period 2Q 2024 Anticipated IMPALA 2 Timelines: ~20-Month Recruitment
Slide 16: Molgramostim Regulatory Landscape
Molgramostim Regulatory Landscape Trial design endorsed by regulatory authorities in the U.S., Canada, Japan, South Korea, and the countries in Europe where the trial is being conducted IMPALA 2 Orphan Drug Designation, Europe (eligible for 10 years exclusivity) Orphan Drug Designation, U.S. (eligib
Slide 17: Financials and Milestones
Financials and Milestones
Slide 18: Financial Overview as of December 31, 2020
Financial Overview as of December 31, 2020 Pro forma cash balance* ~$200M Cash runway sufficient to fund planned operations through 2025 Loan and security agreement (interest only through mid-2022) $25M Common stock* Shares outstanding Fully diluted ~112M ~164M *Reflects completion on March 15, 2021