Savara Inc - SVRA STOCK NEWS

Savara Inc. (SVRA) announced the publication of a manuscript in ERJ Open Research detailing long-term outcomes of molgramostim inhalation solution in treating autoimmune pulmonary alveolar proteinosis (aPAP). The retrospective study evaluated five aPAP patients who received molgramostim through European single-patient access over a mean duration of 4.2 years.

The study demonstrated significant improvements including enhanced lung function, decreased disease burden, and reduced clinical symptoms. Key findings showed improvements in pulmonary gas transfer and activities of daily living. Notably, while four patients required whole lung lavage (WLL) before treatment, none needed it after one year of molgramostim use. The treatment was well-tolerated with no serious adverse events reported.

Savara plans to complete its rolling Biologics License Application (BLA) submission in the U.S. by the end of Q1 2025 and submit a Marketing Authorization Application (MAA) in Europe by the end of 2025.

Savara Inc. (Nasdaq: SVRA), a clinical stage biopharmaceutical company specializing in rare respiratory diseases, has announced its participation in two major healthcare investor conferences in February 2025.

The company's management team will participate in fireside chats at both events:

• The Guggenheim SMID Cap Biotech Conference (February 5-6, 2025), with a fireside chat scheduled for February 5th at 10:00am ET/7:00am PT
• The Oppenheimer 35th Annual Healthcare Life Sciences Conference (February 11-12, 2025), with a fireside chat scheduled for February 11th at 8:00am ET/5:00am PT

Live webcasts and replays will be accessible through Savara's corporate website in the 'Events & Presentations' section, remaining available for 90 days.

Savara Inc. (Nasdaq: SVRA) has granted inducement awards to five new employees as announced by the Compensation Committee of its Board of Directors on December 20, 2024. The awards include options to purchase 100,000 shares of common stock at $3.23 per share and restricted stock units (RSUs) covering 100,000 shares.

The equity awards were granted under Savara's 2021 Inducement Equity Incentive Plan per NASDAQ Rule 5635(c)(4). The options have a 10-year term with quarterly vesting of 1/16th of shares, while RSUs fully vest after two years, both subject to continued employment.

Savara Inc. (Nasdaq: SVRA) has initiated a rolling submission of a Biologics License Application (BLA) to the FDA for MOLBREEVI, targeting the treatment of autoimmune Pulmonary Alveolar Proteinosis (aPAP), a rare lung disease. The company expects to complete the BLA submission by the end of Q1 2025 and will request priority review.

MOLBREEVI has received multiple regulatory designations including Fast Track, Breakthrough Therapy, and Orphan Drug Designation from both FDA and EMA. The drug demonstrated positive results in the Phase 3 IMPALA-2 trial, showing a favorable benefit-risk profile. If approved, MOLBREEVI would be the first approved treatment for aPAP in the U.S. and Europe.

Savara Inc. (Nasdaq: SVRA), a clinical stage biopharmaceutical company specializing in rare respiratory diseases, has announced its participation in the 43rd Annual J.P. Morgan Healthcare Conference. The company's Chair and CEO, Matt Pauls, will present on January 15 at 5:15pm PT/8:15pm ET at the Westin St. Francis in San Francisco. The presentation will be available via live webcast and will remain accessible for 30 days on the company's website.

Savara announced the grant of inducement awards to four new employees on November 20, 2024. The awards include options to purchase 80,000 shares of common stock and restricted stock units (RSUs) covering 70,000 shares. The options have an exercise price of $3.13 per share, with a 10-year term and quarterly vesting over four years. The RSUs vest fully after two years. These equity awards were granted under Savara's 2021 Inducement Equity Incentive Plan in accordance with NASDAQ Listing Rules.

Savara announced an encore presentation of Phase 3 IMPALA-2 trial results for Molgramostim inhalation solution in patients with autoimmune Pulmonary Alveolar Proteinosis (aPAP) at the upcoming British Thoracic Society Winter Meeting 2024. The presentation titled 'Inhaled Molgramostim Improves Pulmonary Gas Exchange and Respiratory Health-Related Quality of Life in Patients with aPAP' will be delivered by Dr. Cormac McCarthy on November 29, 2024, in London. The presentation will showcase how the treatment improves pulmonary gas exchange and respiratory health-related quality of life in aPAP patients.

Savara Inc. (Nasdaq: SVRA), a clinical stage biopharmaceutical company specializing in rare respiratory diseases, has announced its participation in two major healthcare conferences. The company will participate in fireside chats at the Jefferies London Healthcare Conference (November 19-21, 2024) and the Piper Sandler 36th Annual Healthcare Conference (December 3-5, 2024).

The fireside chats are scheduled for November 20th at 1:00pm GT/8:00am ET and December 3rd at 8:30am ET respectively. Live webcasts and replays will be accessible through Savara's corporate website and will remain available for 90 days.

Savara Inc. (SVRA) reported Q3 2024 financial results and business updates. The company plans to initiate a rolling BLA submission for MOLBREEVI by year-end, with completion expected by end of Q1 2025. The company reported a net loss of $24.2 million ($0.11 per share) compared to $16.6 million in Q3 2023. R&D expenses increased 46.5% to $20.3 million, while G&A expenses rose 45% to $6.0 million. With approximately $219.4 million in cash and short-term investments, Savara believes it is capitalized through Q2 2027.