Palvella Therapeutics released its third‑quarter 2025 financial results on November 11, 2025. The company posted a non‑GAAP earnings per share of $‑1.03, missing the consensus estimate of $‑0.86. Revenue remained flat at $0, in line with expectations for a clinical‑stage biopharma that has not yet commercialized a product.
The quarter ended with a net loss of $11.3 million, up from $7.0 million in the same period a year earlier. Research and development expenses climbed to $6.5 million, a 102 % increase from $3.2 million in Q3 2024, while general and administrative costs were $3.6 million. Cash and cash equivalents stood at $63.6 million as of September 30, giving the company a runway that management believes will support operations through the second half of 2027.
The earnings miss is largely attributable to the sharp rise in R&D spending as Palvella advances its QTORIN™ pipeline. The company is investing heavily in Phase 2 and Phase 3 studies for its rare‑skin‑disease candidates, including TOIVA and SELVA, which require significant clinical development costs. With no revenue to offset these outlays, the loss widened relative to analysts’ expectations.
Management emphasized that the cash position provides a comfortable cushion for upcoming milestones. The company expects to deliver topline Phase 2 TOIVA results in mid‑December 2025 and Phase 3 SELVA data in the first quarter of 2026. No new revenue guidance was issued, but the firm reiterated confidence that its cash reserves will sustain operations until the end of 2027.
Investors reacted negatively to the earnings miss, with the market focusing on the wider‑than‑expected loss and the lack of revenue. The EPS miss, combined with the significant increase in R&D expenses, underscored the high cost of advancing a clinical pipeline and tempered enthusiasm for the company’s long‑term prospects.
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