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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) reported a net loss of $10.2 million or $(0.13) per share for Q1 2021, an improvement from a loss of $15.4 million or $(0.27) per share in Q1 2020. The company reduced R&D expenses by 42.5% to $7.6 million, mainly due to the absence of costs related to the acquisition of Apulmiq. Savara raised $130 million in equity, enhancing its cash position to approximately $193 million, expected to fund operations through 2025. The IMPALA-2 trial's site activation is underway, with early patient randomization anticipated by late Q2 or early Q3 2021.
Savara Inc. (Nasdaq: SVRA) announced the completion of an underwritten public offering of 57,479,978 shares of common stock at $1.45 each, raising approximately $130 million before fees. This includes 11,694,150 shares purchased via underwriters' full exercise of their option. Additionally, pre-funded warrants for 32,175,172 shares were sold at $1.449 each. The funds will be allocated towards operational costs, particularly for the clinical development of molgramostim in autoimmune pulmonary alveolar proteinosis and broader working capital needs.
Savara Inc. (Nasdaq: SVRA) has announced the pricing of an underwritten public offering of 45,785,828 shares at $1.45 each, yielding expected gross proceeds of approximately $113 million. Additionally, the company offered pre-funded warrants for 32,175,172 shares at $1.449 each. Proceeds will fund working capital for clinical, regulatory, and commercial activities, particularly related to its molgramostim nebulizer solution for autoimmune pulmonary alveolar proteinosis. The offering is set to close on March 15, 2021, pending customary conditions.
Savara Inc. (Nasdaq: SVRA) announced its intention to offer shares of common stock in an underwritten public offering, also providing certain investors with the option to purchase pre-funded warrants. Proceeds from this offering will primarily support working capital, including clinical development and regulatory activities related to its molgramostim nebulizer for autoimmune pulmonary alveolar proteinosis (aPAP). The offering is subject to market conditions and the underwriters have a 30-day option to purchase an additional 15% of the offering. Jefferies LLC and Piper Sandler are managing the offering.
Savara Inc. (Nasdaq: SVRA) announced updates on its pipeline and company operations, aiming to focus resources on Molgradex for autoimmune pulmonary alveolar proteinosis (aPAP) and the Phase 3 IMPALA 2 trial. The company discontinued the AeroVanc program after failing to meet primary endpoints in the AVAIL trial. Operating expenses will be reduced, including workforce cuts, while cash reserves are expected to be approximately $82 million. The IMPALA 2 trial's start has been pushed to Q2 2021 due to COVID-19 impacts.
Savara Inc. (Nasdaq: SVRA) has announced its participation in upcoming virtual fireside chats at key investor healthcare conferences. The Piper Sandler Annual Healthcare Conference will feature a recorded chat available until December 3, 2020, with a replay on Savara's website. Additionally, the Evercore ISI Annual HealthCONx Conference is scheduled for December 3, 2020, at 12:35 PM EST, with a live webcast accessible online. Both events will have replays for 90 days. Savara focuses on orphan lung diseases, with three investigational inhaled compounds in development.
Savara Inc. (Nasdaq: SVRA), a company focused on orphan lung diseases, announced that Chairman and Interim CEO Matthew Pauls will present at the Jefferies Virtual London Healthcare Conference on November 18, 2020, at 2:55 PM EST. Interested parties can access a live audio webcast via Savara's Investors page. The company’s pipeline includes three inhaled investigational compounds: Molgradex for autoimmune pulmonary alveolar proteinosis, AeroVanc for MRSA lung infections in cystic fibrosis, and Apulmiq for non-CF bronchiectasis.