RARE Daily

Savara Raises $80 Million to Advance Rare Respiratory Diseases Pipeline

July 13, 2023

Rare Daily Staff

Savara raised $80 million through an underwritten offering of stock and warrants to advance its lead candidate for a rare respiratory condition through late-stage development.

The company priced the offering of 21 million shares of its common stock at a price of $3.00 per share and, in lieu of common stock to certain investors that so choose, 5.7 million pre-funded warrants to purchase common stock at a price of $2.999 per pre-funded warrant, in each case before deducting underwriting discounts and commissions, for total gross proceeds of approximately $80 million.

The offering included new investors TCGX, Frazier Life Sciences, and Janus Henderson Investors, as well as existing investors Bain Capital Life Sciences, New Enterprise Associates, Adage Capital Partners, and Venrock Healthcare Capital Partners. The offering is expected to close on July 17, 2023, subject to the satisfaction of customary closing conditions.

Savara’s lead program, molgramostim nebulizer solution, is an inhaled granulocyte-macrophage colony-stimulating factor (GM-CSF) in phase 3 development for autoimmune pulmonary alveolar proteinosis (aPAP).

aPAP is a rare lung disease characterized by the abnormal build-up of surfactant sediment in the alveoli (or air sacs) of the lungs. The surfactant consists of proteins and lipids and is an important physiological substance that lines the inside of the alveoli to prevent the lungs from collapsing. In a healthy lung, the old and inactivated surfactant is cleared and digested by immune cells called alveolar macrophages. Alveolar macrophages need to be stimulated by granulocyte-macrophage colony-stimulating factor (GM-CSF) to function properly in clearing surfactant, but in autoimmune PAP, GM-CSF is neutralized by antibodies against GM-CSF, rendering the macrophages unable to perform their tasks. As a result, an excess of surfactant accumulates in the alveoli, causing obstruction of gas exchange, and patients start to experience shortness of breath, often with cough and frequent fatigue. Patients may also experience chronic cough, as well as episodes of fever, chest pain, or coughing blood, especially if secondary lung infection develops. In the long-term, the disease can lead to serious complications, including lung fibrosis and the need for a lung transplant.

Molgramostim is a novel biologic delivered via an investigational nebulizer, the eFlow Nebulizer System licensed from PARI Pharma. Savara recently completed enrollment in the pivotal phase 3 IMPALA-2 trial, a global, 48-week, placebo-controlled clinical trial evaluating molgramostim. Savara expects to report top line results by the end of the second quarter of 2024.

The U.S. Food and Drug Administration granted Breakthrough Therapy Designation for molgramostim in aPAP in December 2019. In 2022, the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) granted Promising Innovative Medicine designation and Innovative Passport Designation to molgramostim for the treatment of aPAP.

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