LANGHORNE, PA — Savara Inc. (Nasdaq: SVRA) has released its financial results for the second quarter ending June 30, 2024, alongside significant business updates that highlight the company’s progress in clinical trials and strategic developments.
The centerpiece of Savara’s recent achievements is the positive top-line results from the IMPALA-2 trial, a pivotal Phase 3 clinical study evaluating molgramostim nebulizer solution (molgramostim) for the treatment of autoimmune pulmonary alveolar proteinosis (aPAP). The trial demonstrated statistically significant improvements in the primary and secondary endpoints. Specifically, there was a marked enhancement in the Percent Predicted Diffusing Capacity of the Lungs for Carbon Monoxide (DLCO) at weeks 24 and 48. Additionally, there were significant improvements in the St. George’s Respiratory Questionnaire (SGRQ) Total Score at week 24 and notable gains in the SGRQ Activity Score and exercise capacity at week 48. Importantly, 97% of patients completed the double-blind treatment through week 48 without any trial drug-related adverse events leading to discontinuation, and 100% of these patients opted to participate in the subsequent 96-week open-label period.
The FDA has conditionally accepted the trade name MOLBREEVI™ for molgramostim, reflecting a major regulatory milestone for Savara. The company plans to submit a Biologics License Application (BLA) for MOLBREEVI in the first half of 2025.
“Following strong top-line results in the IMPALA-2 trial, we plan to complete the BLA submission for MOLBREEVI, the trade name that the FDA has conditionally accepted for molgramostim, in the first half of 2025,” stated Matt Pauls, Chair and CEO of Savara. “In parallel, we are now significantly ramping up global market development activities and look forward to presenting this work, as well as data from the IMPALA-2 trial, during our investor webinar in September.”
Pauls further commented, “The IMPALA-2 data support our view that MOLBREEVI could fundamentally change the way aPAP is treated. With approximately 3,600 currently diagnosed U.S. patients and literature suggesting prevalence may be underestimated, plus our increased focus on developing the aPAP market and the potential for MOLBREEVI to be the first and only approved therapy for aPAP in the U.S. and Europe, we believe the global commercial opportunity is significant.”
In addition to clinical progress, Savara has strengthened its financial standing. In July 2024, the company completed an equity financing of approximately $100 million, adding around $94 million to the $122 million in cash, cash equivalents, and short-term investments reported as of June 30, 2024. Savara expects this capital to support operations through 2026.
For the second quarter of 2024, Savara reported a net loss of $22.2 million, or $(0.12) per share, compared to a net loss of $11.4 million, or $(0.07) per share, for the same period in 2023. Research and development expenses saw a significant increase of 97.7% to $17.6 million, primarily due to activities related to the molgramostim program. General and administrative expenses also rose by 67.8% to $5.5 million, driven by personnel costs and commercial activities.
Savara’s IMPALA-2 trial results have garnered attention at several upcoming conferences. Abstracts have been accepted for presentation at the European Respiratory Society (ERS) Congress, the CHEST Annual Meeting, and the British Thoracic Society (BTS) Winter Meeting. These presentations will offer new insights into the IMPALA-2 data and the aPAP patient journey. Additionally, Savara will host company-sponsored industry symposia at the ERS Congress and the CHEST Annual Meeting.
Savara’s strategic advancements and financial performance highlight the company’s commitment to developing innovative treatments for rare respiratory diseases, with MOLBREEVI poised to make a significant impact in the aPAP market.
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