Savara(SVRA)2025-05-13 20:03Financial Performance - Savara reported a net loss of $26.6 million for the three months ended March 31, 2025, compared to a net loss of $20.3 million for the same period in 2024, representing an increase of 30.9%[93]. - The total operating expenses for the three months ended March 31, 2025, were $28.4 million, compared to $22.5 million for the same period in 2024, reflecting an increase of $5.9 million[108]. - Cash used in operating activities for Q1 2025 was $27.2 million, an increase from $20.6 million in Q1 2024[116]. - Other income decreased by $0.3 million to $1.8 million for the three months ended March 31, 2025, primarily due to a loss on extinguishment of debt[112]. - The company expects to incur significant additional expenses and continue operating losses for at least the next several years as it advances the clinical development of MOLBREEVI[94]. Research and Development - Research and development expenses increased by $2.4 million, or 14.0%, to $19.2 million for the three months ended March 31, 2025, primarily due to activities related to the MOLBREEVI program[110]. - The company has not generated any revenue from product sales and does not expect to until regulatory approval is obtained[120]. Cash and Investments - As of March 31, 2025, Savara had cash and cash equivalents of $19.6 million and short-term investments of $152.9 million, with an accumulated deficit of approximately $515.9 million[93][113]. - As of March 31, 2025, the company had cash, cash equivalents, and short-term investments totaling approximately $172.5 million[121]. - Cash provided by investing activities was $29.3 million in Q1 2025, compared to $10.8 million in Q1 2024[118]. - Cash provided by financing activities was $2.3 million in Q1 2025, primarily from net proceeds of the Hercules Loan Agreement[119]. Financing Activities - Savara entered into a Hercules Loan Agreement on March 26, 2025, allowing for borrowing up to $200 million, with an initial advance of $30 million used to repay previous obligations[98][113]. - The Hercules Loan Agreement bears interest at 8.95% as of March 31, 2025, with a potential impact from changes in the prime rate[125]. - Future funding requirements may necessitate raising additional capital to support ongoing development and commercialization efforts[122]. - Savara has raised approximately $597.9 million in net cash proceeds since inception, primarily from stock offerings and debt financings[92]. Operational Impact - General and administrative expenses rose by $3.6 million, or 64.1%, to $9.2 million for the three months ended March 31, 2025, driven by personnel costs and commercial activities[111]. - The company has not recognized significant exchange rate losses during Q1 2025 and does not anticipate material effects from currency fluctuations[126]. - Inflation has not materially affected the company's results of operations during the periods presented[127]. Regulatory Developments - The company completed its submission of the Biological License Application (BLA) to the FDA for MOLBREEVI on March 26, 2025, following positive results from the Phase 3 clinical trial[97].