Savara(SVRA) - 2024 Q2 - Quarterly Report

Financial Performance - For the three months ended June 30, 2024, the net loss was $22.2 million, compared to a net loss of$11.4 million for the same period in 2023, representing an increase of 89.5%[66] - For the six months ended June 30, 2024, total operating expenses were $45.7 million, an increase of$21.3 million, or 87.6%, compared to $24.3 million for the same period in 2023[70] - The company has never been profitable and has incurred operating losses every year since inception, with a net loss of$54.7 million for the year ended December 31, 2023[60] - Cash used in operating activities for the six months ended June 30, 2024, was $(43,139) thousand, compared to$(22,298) thousand in 2023, indicating an increase in operational cash outflow[76] Research and Development - Research and development expenses increased by $8.7 million, or 97.7$17.6 million for the three months ended June 30, 2024, primarily due to costs associated with the molgramostim program[66] - Research and development expenses for the six months ended June 30, 2024, were $34.4 million, an increase of$16.8 million, or 95.0%, compared to $17.6 million for the same period in 2023[70] - The company expects to incur significant additional expenses and continue to experience operating losses for at least the next several years as it advances the clinical development of molgramostim[60] Cash and Investments - As of June 30, 2024, the company had cash and cash equivalents of$23.9 million and short-term investments of $97.7 million, with an accumulated deficit of approximately$436.0 million[73] - As of June 30, 2024, the company had cash, cash equivalents, and short-term investments totaling approximately $121.5 million, indicating sufficient capital for planned activities[78] - Cash provided by investing activities was$40.3 million for the six months ended June 30, 2024, primarily from proceeds of short-term investments, partially offset by cash used for purchases of short-term investments[75] Funding and Offerings - The company raised approximately $100.0 million in gross proceeds from a registered direct offering on July 1, 2024, with net proceeds estimated at$93.7 million after expenses[61] - The company sold 26,246,720 shares at an offering price of $3.81 per share on July 1, 2024, resulting in gross proceeds of approximately$100.0 million and estimated net proceeds of $93.7 million after costs[78] - The company anticipates needing additional funding for ongoing development and commercialization efforts, dependent on the pace and results of clinical development[78] Revenue and Profitability - The company has not generated any revenue from product sales and does not expect to until regulatory approval is obtained for its product candidate[78] Other Financial Factors - Other income increased by approximately$0.7 million to $3.1 million for the six months ended June 30, 2024, primarily due to increased interest income from short-term investments[72] - Cash provided by financing activities was minimal for the six months ended June 30, 2024, with only$104 thousand reported[77] - A hypothetical 1% change in interest rates would not have a material impact on the company's financial statements, indicating low interest rate risk exposure[81] - The company has ongoing operations in Europe and seeks to limit foreign currency fluctuations through derivative instruments, with no significant exchange rate losses recognized during the six months ended June 30, 2024[81] - Inflation has not had a material effect on the company's results of operations during the periods presented, despite increasing costs of labor and supplies[81] Administrative Expenses - General and administrative expenses increased by $2.2 million, or 67.8$5.5 million for the three months ended June 30, 2024, driven by personnel and commercial activities[67]