Savara(US:SVRA)2025-08-13 12:05Financial Performance - Savara reported a net loss of $30.4 million for Q2 2025, compared to a net loss of $22.2 million in Q2 2024, representing an increase of 37.1%[94]. - For the six months ended June 30, 2025, the net loss was $57.0 million, up from $42.6 million in the same period of 2024, marking a 33.9% increase[112]. - Cash used in operating activities for the six months ended June 30, 2025, was $53.5 million, compared to $43.1 million in the same period of 2024, reflecting an increase of approximately 24%[118]. - The company has not generated any revenue from product sales and does not expect to until regulatory approval is obtained[122]. Expenses - Research and development expenses increased by $3.1 million, or 17.8%, to $20.8 million for Q2 2025, primarily due to costs related to the MOLBREEVI program[108]. - General and administrative expenses rose by $5.1 million, or 92.3%, to $10.7 million for Q2 2025, driven by personnel additions and commercial activities[109]. - Research and development expenses for the six months ended June 30, 2025, increased by $5.5 million, or 15.9%, to $39.9 million, largely due to chemistry, manufacturing, and controls activities[112]. - General and administrative expenses for the six months ended June 30, 2025, increased by $8.7 million, or 78.1%, to $19.9 million, primarily due to strategic personnel additions[113]. Cash Position - As of June 30, 2025, Savara had cash and cash equivalents of $17.4 million and short-term investments of $129.0 million, with an accumulated deficit of approximately $546.3 million[115]. - As of June 30, 2025, the company had cash, cash equivalents, and short-term investments totaling approximately $146.4 million[123]. Funding and Financing - The company has raised approximately $597.9 million in net cash proceeds since inception, primarily from stock offerings and debt financings[93]. - The company anticipates needing additional funding to support ongoing development and commercialization efforts, contingent on regulatory approval[124]. - The company may finance future cash needs through the issuance of additional equity securities and potentially through borrowings, grants, and strategic alliances[124]. - Cash provided by financing activities was $2.3 million for the six months ended June 30, 2025, compared to $0.1 million in 2024, showing a significant increase[121]. Regulatory and Development Plans - The company plans to resubmit the Biologics License Application (BLA) for MOLBREEVI in December 2025 after receiving a Refusal to File letter from the FDA[92][99]. - Savara expects to incur significant additional expenses and continue operating losses for at least the next several years as it advances clinical development and seeks regulatory approval for MOLBREEVI[95]. Investment Activities - Cash provided by investing activities for the same period was $53.7 million, up from $40.3 million in 2024, indicating a growth of about 33%[118]. - Cash used in investing activities was primarily associated with proceeds from maturities of short-term investments, partially offset by purchases of short-term investments[120]. Other Financial Information - A gain of $0.8 million on foreign currency transactions was recognized for the six months ended June 30, 2025, compared to a loss of $0.3 million in the same period of 2024[130]. - The Hercules Loan Agreement bears interest at 8.95% as of June 30, 2025, with potential impacts from changes in the prime rate on interest expenses[127].