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Item 7.01. Regulation FD Disclosure.
Savara has updated its corporate presentation, which is available on the Investor Relations page of Savara’s website at https://savarapharma.com/investors. A copy of the presentation is furnished as Exhibit 99.1 to this Current Report on Form 8-K. Savara undertakes no duty or obligation to update or revise the information contained in this presentation, although it may do so from time to time. Any such updates may be made through the Investor Relations page of the Savara website, the filing of other reports or documents with the U.S. Securities and Exchange Commission, press releases, or other public disclosure.
The information in Item 7.01 in this Current Report on Form 8-K shall not be deemed “filed” for purposes of Section 18 of the Exchange Act, or otherwise subject to the liabilities of that Section, nor shall it be incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as shall be expressly set forth by specific reference in such filing.
Item 9.01. Financial Statements and Exhibits.
|99.1||Savara Corporate Presentation|
|104||Cover Page Interactive Data File (embedded within the Inline XBRL document).|
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
|Date: March 16, 2021||SAVARA INC.|
|a Delaware corporation|
|Chief Financial Officer|
Savara Corporate Presentation (NASDAQ: SVRA) March 2021 Exhibit 99.1
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 “will,” among others. Such statements include, but are not limited to, statements regarding the nature, strategy and focus of our organization; the timing, design and other matters related to clinical trials of our product candidate; the safety, efficacy and projected development timeline of our product candidate; the potential health benefits of our product candidate; our anticipated corporate milestones and the market size or commercial potential for our product; and the sufficiency of our resources to fund the advancement of our development program and potential sources of additional capital. Savara may not actually achieve any of its plans or product development goals in a timely manner, if at all, or otherwise carry out its current intentions or meet the expectations or projections disclosed in its forward-looking statements, and you should not place undue reliance on these forward-looking statements. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. These forward-looking statements are based upon Savara's current expectations and involve assumptions that may never materialize or may prove to be incorrect. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties, which include, without limitation, the risks and uncertainties related to the impact of the COVID-19 pandemic on our business and operations; the outcome of our future interactions with regulatory authorities; risks and uncertainties associated with the ability to project future cash utilization and reserves needed for contingent future liabilities and business operations; the availability of sufficient resources for our operations and to conduct or continue planned clinical development programs; the timing and ability of Savara to raise additional capital as needed to fund continued operations; the ability to successfully conduct clinical trials for our product candidate; the ability to successfully develop our product candidate; and the risks associated with the process of developing, obtaining regulatory approval for and commercializing drug candidates that are safe and effective for use as human therapeutics. The risks and uncertainties facing Savara are described more fully in Savara's filings with the Securities and Exchange Commission including our filings on Form 8-K and our Annual Report on Form 10-K for the fiscal year ended December 31, 2020. You are cautioned not to place undue reliance on our forward-looking statements, which speak only as of the date on which they were made. Savara undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as may be required by law. Third-party information included herein has been obtained from sources believed to be reliable, but the accuracy or completeness of such information is not guaranteed by, and should not be construed as a representation by, the Company. The trademarks included herein are the property of the owners thereof and are used for reference purposes only. Such use should not be construed as an endorsement of such products.
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
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 pulmonary alveolar proteinosis (aPAP) June 2019: Announced top line results from Phase 3 IMPALA trial Joined Savara from AstraZeneca For 16 years, served as Director, Division of Pulmonary, Allergy, and Rheumatology Products, Center for Drug Evaluation and Research (CDER) at the FDA Nov. 2019: Appointed Badrul Chowdhury, M.D., Ph.D as Chief Medical Officer Focused resources on molgramostim in aPAP Updated guidance on IMPALA 2 trial initiation to Q2 2021 Discontinued development of vancomycin inhalation powder (AeroVanc) and inhaled ciprofloxacin (Apulmiq) Dec. 2020: Reprioritization of Pipeline Sept. 2020: IMPALA results published in New England Journal of Medicine Data demonstrating synchronous improvement across multiple outcome measures that reflect physiological, clinical, radiologic, and biochemical disease manifestations provide strong support for a beneficial treatment effect of molgramostim in aPAP Member of Savara’s Board of Directors since 2017 Extensive experience and expertise in rare disease sector Dec. 2020: Appointed Matthew Pauls, Chairman and Interim CEO since Sept. 2020, to Chairman and Permanent CEO Q2 2021: Initiate Phase 3 IMPALA 2 trial by end of quarter, leveraging key learnings from first IMPALA trial Q2 2024: Anticipate top line data read out from IMPALA 2 trial Upcoming Catalysts * Molgramostim, formerly referred to as Molgradex.
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 Lowrance Chief Financial Officer
Molgramostim for Autoimmune Pulmonary Alveolar Proteinosis (aPAP) Molgramostim
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 and reduce surfactant clearance Surfactant accumulation causes altered gas exchange in the lung, reduced blood oxygenation, and, ultimately, hypoxemic respiratory failure Baseline (Week 0) After Treatment (Week 24) aPAP PATIENT From IMPALA trial
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. placebo 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. placebo = Primary efficacy analyses Screening BL n=45 Period 1: Double-blind W 8 W 24 W 16 Period 2: Open-label n=45 n=47 W 48 molgramostim 300 µg daily dosing molgramostim 300 µg intermittent placebo
Published online on 9/2/2020. IMPALA Trial Results Published in New England Journal of Medicine in September 2020
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 patients using supplemental oxygen during testing (placebo: n=2, intermittent: n=1, continuous: n=1). 1: Trapnell, Inhaled Molgramostim Therapy in aPAP, NEJM, 2020. 1
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 (SGRQ) From Baseline Over 24-weeks (FAS) OD estimated treatment difference of 7.6 points (p=0.01) Results not adjusted for multiplicity. IMPALA 2 Primary Endpoint IMPALA 2 Secondary Endpoint 1: Trapnell, Inhaled Molgramostim Therapy in aPAP, NEJM, 2020. 1 1
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 period. Mean Change in DLCO Over Time n=44 n=46 n=43 n=42 n=40 n=41 n=19 n=18 Use of WLL During the Blinded Treatment Period 1: Trapnell, Inhaled Molgramostim Therapy in aPAP, NEJM, 2020. 1 1 1
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 / safety Secondary Endpoints Primary Endpoint 6-Week Screening BL molgramostim 300 µg daily dosing Period 1: Double-blind W 24 W 48 Period 2: Open-label W 96 Placebo molgramostim 300 µg daily dosing n=80 n=80 IMPALA 2 will be conducted at ~50 sites across ~14 countries. Patients needing WLL will have procedure prior to screening. DLCO measured at 6 and 3 weeks to baseline to assure stability (DLCO <15 % predicted)
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 countries N. America, Europe, Japan, S. Korea Enrollment duration:32 months, peak enrollment = 8 p/month Supplemental oxygen:Allowed as background and during efficacy measure (n=4) Disease severity:Stable moderate to severe disease Primary endpoint:Gas Exchange: DLCO (surrogate endpoint) Secondary endpoints:SGRQ Total (direct patient benefit)SGRQ Activity Exercise capacity test using treadmill Device:Pari e-Flow Nebulizer System Number of trial sites: ~50 Geographies: ~14 countries N. America, Europe, Japan, S. Korea Enrollment duration:~20 months Supplemental oxygen:Will be allowed as background, NOT during efficacy measure Disease severity:Stable moderate to severe disease
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
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. (eligible for 7 years exclusivity) Fast Track Designation Breakthrough Therapy Designation MOLGRAMOSTIM IN aPAP REGULATORY DESIGNATIONS Upon Biologics License Application (BLA) approval FDA would grant 12 years marketing exclusivity BIOLOGIC EXCLUSIVITY
Financials and Milestones
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 of an underwritten public offering resulting in net proceeds of $122M to the Company.