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Savara Inc. develops therapies for rare respiratory diseases, with a lead program in molgramostim inhalation solution, conditionally named MOLBREEVI, for autoimmune pulmonary alveolar proteinosis. Molgramostim is a recombinant human GM-CSF delivered through an investigational eFlow Nebulizer System developed for inhalation of the large-molecule therapy.
Recurring company developments include clinical data from the IMPALA-2 program, regulatory submissions and agency-review updates in the U.S., Europe and the U.K., financial results, financing arrangements, equity inducement grants and investor conference participation. Savara's updates also note that MOLBREEVI is not approved in any indication.
Savara Inc. (NASDAQ: SVRA), a clinical stage biopharmaceutical company specializing in rare respiratory diseases, announced on January 17, 2023 that it granted inducement awards to two new employees. The awards consist of options to purchase a total of 195,000 shares of common stock and restricted stock units (RSUs) covering 60,000 shares. The options have an exercise price of $1.89 per share, equal to the closing stock price on the grant date. Each option vests quarterly over a 10-year term, while the RSUs fully vest two years after the new employees' start date. The awards are part of Savara's 2021 Inducement Equity Incentive Plan.
Savara Inc. (NASDAQ: SVRA), focused on rare respiratory diseases, announced an employee inducement award granted to Dr. Raymond Pratt, who joined as Chief Medical Officer on November 10, 2022. This award includes options to purchase 375,000 shares and restricted stock units for 150,000 shares, made under the 2021 Inducement Equity Incentive Plan. The option exercise price is $1.43, equivalent to the closing price on the grant date. Options vest quarterly over four years, while RSUs fully vest after two years, contingent on continued employment.
Savara Inc. (SVRA) reported its financial results for Q3 2022, highlighting a net loss of $10.4 million, consistent with the previous year. Research and development expenses rose by 24.8% to $8.2 million, driven by costs associated with the ongoing Phase 3 IMPALA-2 trial for molgramostim, an inhaled biologic for aPAP. The company ended the quarter with approximately $134 million in cash, expected to sustain operations through 2025. Additionally, Savara announced the appointment of Raymond Pratt, M.D. as Chief Medical Officer.
Savara Inc. (Nasdaq: SVRA), a clinical stage biopharmaceutical company focused on rare respiratory diseases, announced its participation in three upcoming healthcare conferences. These include the Jefferies London Healthcare Conference on November 16, 2022, the Piper Sandler 34th Annual Healthcare Conference on November 29, 2022, and the Evercore ISI 5th Annual HealthCONx Conference on November 30, 2022. Each event will feature corporate presentations and a fireside chat. Webcasts of these presentations will be archived on Savara's website for 90 days.
Savara Inc. (NASDAQ: SVRA), a clinical-stage biopharmaceutical company, announced the grant of inducement awards to three new employees on September 13, 2022. These awards include options for 190,000 shares and RSUs for 75,000 shares, part of the 2021 Inducement Equity Incentive Plan. The options have an exercise price of $1.46 per share and vest quarterly over 10 years. Savara focuses on rare respiratory diseases, with its lead program, molgramostim, in Phase 3 development for autoimmune pulmonary alveolar proteinosis (aPAP).
Savara Inc. (NASDAQ: SVRA) presented three posters at the ERS International Congress 2022 in Barcelona, focusing on autoimmune pulmonary alveolar proteinosis (aPAP). Key findings include a post hoc analysis from the IMPALA trial showing improved gas exchange and health status in patients treated with inhaled molgramostim compared to placebo. Safety data from the IMPALA-X study indicated no new safety signals. The company highlighted the rationale for using DLco as a primary endpoint in the ongoing IMPALA-2 trial, aiming to demonstrate the efficacy of molgramostim in aPAP.
Savara Inc. (NASDAQ: SVRA), a biopharmaceutical firm targeting rare respiratory diseases, announced that CEO Matt Pauls will present at the H.C. Wainwright 24th Annual Global Investment Conference from September 12-14, 2022. The presentation is scheduled for 7:00 AM ET/4:00 AM PT on September 12, 2022, and will be accessible via a webcast on Savara’s website, where it will remain archived for 90 days. Savara’s lead product, molgramostim nebulizer solution, is in Phase 3 development for autoimmune pulmonary alveolar proteinosis (aPAP).
Savara Inc. (NASDAQ: SVRA) announced the resignation of Chief Medical Officer Badrul Chowdhury, effective September 9, 2022. The company expressed appreciation for his contributions, particularly in advancing the molgramostim nebulizer solution for autoimmune pulmonary alveolar proteinosis (aPAP). Chowdhury leaves with confidence in the ongoing Phase 3 IMPALA-2 trial. Savara focuses on rare respiratory diseases, with molgramostim being a key product in development, delivered via the investigational eFlow® Nebulizer System.
Savara Inc. (NASDAQ: SVRA) announced its molgramostim received Promising Innovative Medicine (PIM) designation from the UK’s MHRA for treating autoimmune pulmonary alveolar proteinosis (aPAP). This designation enhances molgramostim’s chance for early access under the UK’s Early Access to Medicines Scheme (EAMS), allowing potential patient use 12-18 months prior to formal marketing authorization. Previous recognitions include Fast Track and Breakthrough Therapy designations from the FDA.
Savara Inc. (Nasdaq: SVRA) reported its financial results for Q2 2022, noting a net loss of $9.2 million, or $(0.06) per share, an improvement from the previous year's loss of $10.9 million. Research and development expenses decreased by 11.5% to $6.4 million, attributed to timing in contract research costs. The pivotal Phase 3 IMPALA-2 trial of Molgramostim remains on track for top-line data by the end of Q2 2024. The company holds approximately $142 million in cash, indicating sufficient funding through 2025.