Savara(SVRA)2024-11-12 21:00Financial Performance - Savara reported a net loss of $24.2 million for Q3 2024, compared to a net loss of $16.6 million in Q3 2023, reflecting an increase of $7.6 million or 45.8%[70] - For the nine months ended September 30, 2024, net loss was $66.8 million, an increase of $28.2 million or 73.1% compared to the same period in 2023[71] - Cash used in operating activities for the nine months ended September 30, 2024, was $65.8 million, resulting from a net loss of $66.8 million and changes in operating assets and liabilities[74] Research and Development Expenses - Research and development expenses increased by $6.4 million, or 46.5%, to $20.3 million for Q3 2024, primarily due to costs associated with the molgramostim program[70] - Research and development expenses for the nine months ended September 30, 2024, increased by $23.2 million, or 73.7%, to $54.7 million, largely due to molgramostim-related activities[71] General and Administrative Expenses - General and administrative expenses rose by $1.9 million, or 45.0%, to $6.0 million for Q3 2024, driven by personnel and commercial activities[70] Cash and Investments - As of September 30, 2024, Savara had cash and cash equivalents of $21.4 million and short-term investments of $198.0 million[71] - As of September 30, 2024, the company had cash, cash equivalents, and short-term investments of approximately $219.4 million[77] - Cash used in investing activities totaled $57.8 million, primarily for purchases of short-term investments[75] Financing Activities - The company raised approximately $594.9 million in net cash proceeds since inception, primarily through stock offerings and debt financings[62] - In July 2024, Savara completed an underwritten offering, selling 26,246,720 shares at $3.81 per share, resulting in net proceeds of $93.8 million[64] - The July 2024 Offering generated net proceeds of $93.8 million from the sale of 26,246,720 shares at an offering price of $3.81 per share[77] - The company sold 6,038,650 shares on August 14, 2024, resulting in net proceeds of $24.4 million[78] - Cash provided by financing activities was $118.4 million, mainly from net proceeds of the July 2024 Offering and the August 14, 2024 sales offering[76] Regulatory and Product Development - The Early Access Program for molgramostim was launched on September 27, 2024, allowing eligible patients access in select regions[65] - Savara plans to submit a Biological License Application for molgramostim to the FDA in Q1 2025[62] - The company has not generated any revenue from product sales and does not expect to until regulatory approval is obtained[77] Market and Economic Conditions - Future funding requirements will depend on the pace of clinical development and regulatory efforts, with potential needs for additional capital[78] - The company has market risk exposure related to cash and short-term investments, but does not anticipate material risks from interest rate changes[81] - Inflation has not had a material effect on the company's results of operations during the periods presented[81]