Soleno Therapeutics Reports $43.8 Million Net Loss in Q1 2025 Amid VYKAT XR Launch

Soleno Therapeutics, Inc. reported a net loss of $43.8 million for the first quarter of 2025, a significant increase from the $21.4 million loss recorded in the same period of 2024. The company's operating expenses surged to $45.7 million, up 95% from $23.5 million year-over-year, primarily driven by a 245% increase in selling, general, and administrative expenses, which rose to $29.3 million. Research and development expenses decreased slightly to $13.5 million from $14.6 million, reflecting a shift in focus towards commercialization efforts following the FDA approval of its lead product, VYKAT XR, on March 26, 2025.

The company’s total assets decreased to $318.1 million as of March 31, 2025, down from $331.0 million at the end of 2024. Cash and cash equivalents stood at $81.3 million, while marketable securities increased to $208.6 million. Soleno's accumulated deficit reached $496.0 million, reflecting ongoing losses since its inception. The company utilized $32.8 million in cash for operating activities during the quarter, compared to $12.5 million in the same period last year.

In terms of strategic developments, Soleno launched VYKAT XR, which is indicated for treating hyperphagia in patients with Prader-Willi syndrome. Following the FDA approval, the company began delivering prescriptions to patients in April 2025. The approval has opened up additional funding opportunities, with an existing loan agreement with Oxford Financing LLC allowing for an additional $50 million in funding following the approval of VYKAT XR. The company anticipates generating revenue from this product in the upcoming quarter.

Operationally, Soleno has expanded its workforce significantly, increasing its employee count to 115 as of March 31, 2025, up from 92 at the end of 2024. This growth is part of the company's strategy to bolster its sales and marketing capabilities in preparation for the commercial launch of VYKAT XR. The company is also preparing for a Marketing Authorization Application (MAA) submission in Europe, expected in the second quarter of 2025.

Looking ahead, Soleno expects to continue incurring losses as it invests in the commercialization of VYKAT XR. The company believes its current cash and marketable securities will be sufficient to meet its operational needs for at least the next twelve months. However, it acknowledges the potential need for additional capital to support its growth and operational strategies, particularly as it navigates the complexities of launching its first commercial product.