Savara's $100M raise driven by lung disease success

Savara has made significant strides in the development of its treatment for autoimmune pulmonary alveolar proteinosis (aPAP) following promising results from a recent Phase III trial. Earlier this week, the company shared positive data regarding its experimental therapy, molgramostim nebuliser, an inhaled form of granulocyte-macrophage colony-stimulating factor (GM-CSF). This progress has enabled Savara to successfully raise $100 million through the sale of just over 26 million shares, each priced at $3.81.

The key milestone achieved by Savara's molgramostim nebuliser was meeting the primary endpoint in the IMPALA-2 study. The treatment demonstrated a statistically significant 6% improvement in the diffusing capacity of the lungs for carbon monoxide (DLCO) compared to a placebo at the 24-week mark. This outcome is particularly noteworthy as DLCO is a critical measure of lung function, reflecting the ability of the lungs to transfer gas from the air into the bloodstream.

Savara has ambitious plans following these successful trial results. The company intends to file a regulatory application for molgramostim with the U.S. Food and Drug Administration (FDA) in the first half of 2025. If approved and brought to market, analysts at Jefferies project that the drug could achieve peak sales exceeding $400 million annually in the United States.

Following the announcement of these positive Phase III results, Savara’s shares experienced a notable uptick, rising approximately 7% on Friday. This increase in share price reflects the market's confidence in the potential of molgramostim to address the unmet needs of patients with autoimmune pulmonary alveolar proteinosis.

In summary, Savara's recent advancements in developing molgramostim nebuliser for aPAP are promising. The IMPALA-2 study's positive outcomes and subsequent financial backing underscore the company's potential to bring a significant new treatment to market. With regulatory submission plans set for 2025, Savara is poised to make a substantial impact on the treatment landscape for aPAP if regulatory approval is granted.