Zevra Therapeutics, Inc. reported significant financial developments in its recent 10-Q filing for the quarter ending September 30, 2024. The company, which focuses on therapeutics for rare diseases, experienced a net loss of $33.2 million for the three months ended September 30, 2024, compared to a net loss of $10.4 million for the same period in 2023. For the nine months ended September 30, 2024, the net loss increased to $69.8 million from $26.2 million in the prior year. This increase in losses is attributed to higher operating expenses, particularly in selling, general, and administrative costs, which rose to $16.2 million for the quarter, up from $5.8 million in the previous year.

Revenue for the third quarter of 2024 was $3.7 million, an increase from $2.9 million in the same quarter of 2023. This growth was driven by a $0.3 million increase in royalties and reimbursements under the AZSTARYS License Agreement and a $0.5 million rise in French Expanded Access Program (EAP) reimbursements. However, total revenue for the nine months ended September 30, 2024, decreased to $11.6 million from $14.5 million in the prior year, primarily due to lower revenue from the AZSTARYS License Agreement.

The company’s total assets increased to $191.6 million as of September 30, 2024, up from $172.3 million at the end of 2023. Cash and cash equivalents also rose to $54.0 million from $43.0 million during the same period. However, long-term debt surged to $58.9 million, a significant increase from $5.1 million at the end of 2023, reflecting the company’s reliance on debt financing to support its operations and growth initiatives.

Zevra completed the acquisition of Acer Therapeutics on November 17, 2023, which expanded its portfolio to include OLPRUVA and investigational products like celiprolol. The company also received FDA approval for MIPLYFFA (arimoclomol) on September 20, 2024, marking a significant milestone as the first treatment for Niemann-Pick disease type C. Despite these advancements, Zevra has expressed substantial doubt about its ability to continue as a going concern due to ongoing operating losses and negative cash flows.

The company has initiated various financing activities, including an August 2024 offering that raised approximately $64.5 million, intended for commercial launch activities and product development. Zevra's accumulated deficit reached $469.6 million as of September 30, 2024, highlighting the financial challenges it faces as it seeks to establish a sustainable revenue stream from its product offerings.