Savara Reports Third Quarter 2022 Financial Results and Provides Business Update

On November 11, 2022 Savara Inc. (Nasdaq: SVRA), a clinical stage biopharmaceutical company focused on rare respiratory diseases, reported financial results for the third quarter ending September 30, 2022 and provided a business update (Press release, Savara, NOV 11, 2022, View Source [SID1234623878]).

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"As we’ve said over the last year, challenges related to COVID and flu surges, geopolitical issues, and supply chain constraints are ongoing and will likely continue," said Matt Pauls, Chair and CEO, Savara. "However, IMPALA-2, the pivotal Phase 3 trial of our novel inhaled biologic, remains on-track for a top line read-out by the end of 2Q 2024. Importantly, the Company has a strong balance sheet, and we believe we have more than three years of operating runway which is approximately 18 months beyond top line results. Finally, we are happy to announce the appointment of Raymond Pratt, M.D. as Chief Medical Officer, effective immediately. With approximately 30 years of global drug development experience, and numerous regulatory approvals, Dr. Pratt is a proven biopharmaceutical Chief Medical Officer, and we are confident that he will provide significant clinical development, medical affairs, and regulatory leadership."

"I am delighted to join Savara as we advance the molgramostim development program," said Raymond Pratt, M.D., newly appointed Chief Medical Officer, Savara. "I am impressed by the quality of the team and progress they have made executing the IMPALA-2 trial. I look forward to building on that momentum so that we can potentially fill the serious unmet needs of patients with aPAP."

Third Quarter Financial Results (Unaudited)

Savara’s net loss attributable to common stockholders for the three months ended September 30, 2022, was $10.4 million, or $(0.07) per share, compared with a net loss attributable to common stockholders of $10.5 million, or $(0.07) per share, for the three months ended September 30, 2021.

Research and development expenses increased by $1.6 million, or 24.8%, to $8.2 million for the three months ended September 30, 2022 from $6.5 million for the three months ended September 30, 2021. This was primarily due to approximately $0.7 million of costs related to our IMPALA-2 trial, including activities related to our Contract Research Organization and approximately $0.7 million of costs related to our Chemistry, Manufacturing, and Controls (CMC) activities.

General and administrative expenses decreased by $1.0 million, or 30.1%, to $2.4 million for the three months ended September 30, 2022 from $3.4 million for the three months ended September 30, 2021. This was primarily attributable to a reduction of approximately $0.7 million in consulting activities during the three months ended September 30, 2022.

As of September 30, 2022, Savara had cash, cash equivalents, and short-term investments of approximately $134 million and debt of approximately $26 million.