Palvella Therapeutics Inc (NASDAQ:PVLA) Reports Wider Q2 2025 Loss, Stock Drops 13% Despite Clinical Progress

Palvella Therapeutics Inc (NASDAQ:PVLA [https://www.chartmill.com/stock/quote/PVLA]) reported its second-quarter 2025 financial results, posting a net loss of $0.86 per share, missing analyst estimates of a $0.76 loss. Revenue for the quarter remained at $0.0, in line with expectations, as the company is still in the clinical-stage development phase with no commercialized products. The stock reacted negatively in pre-market trading, dropping over 13%, likely reflecting investor disappointment over the wider-than-expected loss despite progress in clinical trials.

FINANCIAL PERFORMANCE VS. ESTIMATES

* EARNINGS PER SHARE (EPS): Reported at -$0.86, compared to the estimated -$0.76, reflecting higher operational expenses.
* REVENUE: Reported $0.0, matching expectations, as Palvella has yet to generate product sales.
* CASH POSITION: The company ended the quarter with $70.4 MILLION IN CASH AND EQUIVALENTS, projecting sufficient funding into the second half of 2027.

MARKET REACTION

The pre-market decline suggests investors were anticipating a narrower loss, given the company’s progress in clinical trials. However, the sell-off may also reflect broader market caution toward pre-revenue biotech firms, particularly those with extended timelines to commercialization.

KEY HIGHLIGHTS FROM THE PRESS RELEASE

*
CLINICAL TRIAL PROGRESS:

* The PHASE 3 SELVA TRIAL for QTORIN™ rapamycin in microcystic lymphatic malformations completed enrollment, exceeding targets by 25%. Top-line results are expected in Q1 2026.
* The PHASE 2 TOIVA TRIAL for cutaneous venous malformations remains on track for Q4 2025 results.
* Palvella plans to announce a THIRD CLINICAL INDICATION and a SECOND QTORIN™ PLATFORM CANDIDATE by year-end.

*
REGULATORY AND INTELLECTUAL PROPERTY MILESTONES:

* Received an FDA ORPHAN PRODUCTS GRANT (up to $2.6 million) to support the SELVA trial.
* Strengthened patent protection with new USPTO issuances extending into 2038.

*
CORPORATE DEVELOPMENTS:

* Added to the RUSSELL 3000® AND RUSSELL 2000® INDEXES in late June.
* Appointed rare disease commercialization expert ASHLEY KLINE as Chief Commercial Officer.

OUTLOOK VS. ANALYST ESTIMATES

While Palvella did not provide explicit financial guidance, analysts project:

* Q3 2025 EPS ESTIMATE: -$0.80
* FULL-YEAR 2025 EPS ESTIMATE: -$3.01
* REVENUE EXPECTATIONS: No sales anticipated in 2025.

Given the company’s cash runway and upcoming clinical catalysts, long-term investors may focus on trial readouts rather than near-term financials.

For more detailed earnings estimates and historical performance, view Palvella’s earnings and estimates page [https://www.chartmill.com/stock/quote/PVLA/earnings-estimates].

DISCLAIMER: This article is not investment advice. Investors should conduct their own research and consider risk factors before making decisions.