Palvella Therapeutics Reports $9.5 Million Net Loss in Q2 2025 Amid Increased R&D Expenses

Palvella Therapeutics, Inc. reported significant financial results for the second quarter of 2025, reflecting a net loss of $9.5 million, compared to a loss of $4.4 million in the same period of the previous year. For the first half of 2025, the company recorded a net loss of $17.7 million, up from $7.1 million in the first half of 2024. The increase in losses is attributed to heightened operating expenses, which totaled $9.3 million for the quarter and $17.1 million for the six months, compared to $2.9 million and $4.7 million, respectively, in the prior year. The rise in expenses is primarily due to increased research and development activities related to the clinical trials of the company’s lead product candidate, QTORIN rapamycin.

The company’s operating expenses surged due to a substantial increase in research and development costs, which reached $5.1 million for the second quarter, compared to $1.4 million in the same quarter of 2024. This increase is largely driven by the ongoing Phase 3 SELVA trial for microcystic lymphatic malformations and the Phase 2 TOIVA trial for cutaneous venous malformations. General and administrative expenses also rose significantly, totaling $4.1 million for the quarter, up from $1.5 million in the prior year, reflecting the costs associated with operating as a public company following the merger with Legacy Palvella.

Palvella's cash and cash equivalents stood at $70.4 million as of June 30, 2025, a decrease from $83.6 million at the end of 2024. The company reported net cash used in operating activities of $12.2 million for the first half of 2025, compared to $2.7 million in the same period of 2024. The decrease in cash is attributed to the increased operational expenditures and the costs associated with the merger completed in December 2024, which was treated as a reverse recapitalization for accounting purposes.

In terms of strategic developments, Palvella has made progress in its clinical trials, successfully completing enrollment in the SELVA trial with 51 subjects, exceeding the initial target of 40 participants. The company also received a $0.5 million grant from the FDA to support the SELVA trial, further bolstering its financial position. Additionally, Palvella has been granted Breakthrough Therapy Designation and Orphan Drug Designation for QTORIN rapamycin, indicating the potential for expedited regulatory review.

Looking ahead, Palvella anticipates continued losses as it advances its product candidates through clinical trials and regulatory submissions. The company does not expect to generate commercial revenue for several years and will need to secure additional financing to support its operations and development activities. Management believes that the existing cash balance will be sufficient to fund operations into the second half of 2027, but acknowledges the need for future capital raises to sustain growth and development efforts.