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PVLA

Palvella Therapeutics, Inc.

PVLA

Palvella Therapeutics, Inc. • NASDAQ
$102.79 ▲ 2.80% (+2.80)
Market Cap $1.22 B
52w High $106.71
52w Low $11.17
Dividend Yield 0%
P/E -35.2
Volume 229.93K
Outstanding Shares 11.84M

Income Statement

Period Revenue Operating Expense Net Income Net Profit Margin Earnings Per Share EBITDA
Q3-2025 $0 $10.177M ▲ $-11.345M ▼ 0% $-1.03 ▼ $342K ▲
Q2-2025 $0 $9.25M ▲ $-9.471M ▼ 0% $-0.86 ▲ $-8.117M ▼
Q1-2025 $0 $7.871M ▲ $-8.185M ▼ 0% $-3.68 ▼ $-6.97M ▼
Q3-2024 $0 $5.062M ▲ $-6.775M ▼ 0% $-2.19 ▲ $0 ▲
Q2-2024 $0 $2.908M $-4.172M 0% $-3.37 $-3.115M

Balance Statement

Period Cash & Short-term Total Assets Total Liabilities Total Equity
Q3-2025 $63.567M ▼ $66.937M ▼ $28.255M ▲ $38.682M ▼
Q2-2025 $70.433M ▼ $73.747M ▼ $25.967M ▲ $47.78M ▼
Q1-2025 $75.626M ▲ $79.439M ▲ $23.862M ▲ $55.577M ▲
Q3-2024 $19.363M ▼ $20.522M ▼ $4.254M ▼ $16.268M ▼
Q2-2024 $19.731M $25.051M $6.346M $18.705M

Cash Flow Statement

Period Net Income Cash From Operations Cash From Investing Cash From Financing Net Change Free Cash Flow
Q3-2025 $-11.345M ▼ $0 ▲ $0 $0 ▼ $-6.866M ▼ $0 ▲
Q2-2025 $-9.471M ▼ $-5.434M ▲ $0 $349K ▲ $-5.193M ▼ $-5.434M ▲
Q1-2025 $-8.185M ▼ $-6.768M ▼ $0 $-1.202M ▼ $56.263M ▲ $-6.768M ▼
Q1-2024 $-2.536M ▲ $-1.102M ▲ $0 ▼ $0 ▼ $-1.102M ▲ $-1.102M ▲
Q4-2023 $-4.584M $-19.669M $3.449M $14K $-15.498M $-19.656M

Five-Year Company Overview

Income Statement

Income Statement Palvella is still essentially a pre-revenue, clinical‑stage biotech. Past years show almost no recurring sales and a steady pattern of operating losses, which is normal for a company funding drug development rather than selling approved products. The one year of positive profit and EBITDA looks more like a one‑off or accounting effect than a sign of a stable, profitable business. Per‑share figures are very volatile, largely because of the recent reverse stock split, not because the underlying business suddenly changed. Overall, the income statement reflects an R&D‑heavy company still in the investment and trial phase, with commercial upside entirely tied to future approvals.

Balance Sheet

Balance Sheet Historically, the balance sheet has been small and simple, dominated by cash and with very little debt. Equity swung from slightly negative to clearly positive, suggesting that past fund‑raising and the merger have recapitalized the company. Most of the assets are in cash or equivalents, which is typical for a lean biotech without big physical operations. The narrative indicates management believes current cash can fund operations for several years, which, if accurate, lowers near‑term funding pressure but does not eliminate longer‑term financing needs. Overall, the balance sheet looks light on leverage but also fully dependent on external capital and future trial success to sustain and grow.

Cash Flow

Cash Flow Cash flows show a consistent pattern of cash being used rather than generated, driven by research, clinical trials, and overhead. Operating cash burn has been steady and moderate, with free cash flow essentially mirroring operating cash flow because there is almost no spending on property or equipment. This is typical for an asset‑light drug developer, where the main costs are people, trials, and regulatory work. The key question is not current profitability, but whether the existing cash runway is long enough to get through the major upcoming trials and regulatory milestones without disruptive additional financing.

Competitive Edge

Competitive Edge Palvella is carving out a focused niche in rare genetic skin diseases, where there are few or no approved treatments and limited direct competition. Its QTORIN platform and lead QTORIN rapamycin gel benefit from multiple FDA designations that can speed review and support market exclusivity, reinforcing its competitive moat in these specific diseases. The company’s strategy is to be “first in disease” for several underserved conditions, which can create a defensible position with specialized prescribers and patient groups. However, Palvella is still small, pre‑commercial, and unproven in launching products, while larger pharma or biotech players could later target overlapping areas if the opportunity proves attractive.

Innovation and R&D

Innovation and R&D Innovation is the core of Palvella’s story: the QTORIN topical delivery platform is designed to push established molecules deeper into the skin while limiting systemic exposure. The lead program, a high‑strength rapamycin gel, is in late‑stage trials for multiple rare vascular and genetic skin conditions, which together form a “pipeline‑in‑a‑product” strategy. Additional candidates and indications, such as QTORIN pitavastatin and other mTOR‑driven diseases, extend the platform’s reach and diversify future options, but most value is still concentrated in a single technology and flagship drug. The upcoming Phase 2 and Phase 3 data readouts over the next couple of years are pivotal: success could validate the platform and unlock a series of follow‑on programs, while disappointment would materially weaken the R&D story.

Summary

Palvella is a classic clinical‑stage biotech: minimal historical revenue, ongoing operating losses, and a balance sheet built to fund R&D rather than generate near‑term profits. Its financial health hinges on disciplined cash use and the belief that current funds can support operations through key trial milestones, with very little debt offering some flexibility. Strategically, the company’s value proposition is tightly linked to its QTORIN platform and lead rapamycin gel, targeting rare dermatologic conditions with high unmet need and supportive regulatory designations. The opportunity is significant but concentrated and binary: future outcomes in clinical trials, regulatory reviews, and the initial commercial launch will likely drive the company’s longer‑term trajectory much more than past financial statements.

NEWS

November 11, 2025 · 7:30 AM UTC

Palvella Therapeutics Reports Third Quarter 2025 Financial Results and Provides Corporate Update

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November 6, 2025 · 7:30 AM UTC

Palvella Therapeutics to Present at the Stifel 2025 Healthcare Conference

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November 5, 2025 · 6:00 AM UTC

Palvella Therapeutics Announces New QTORIN™ Product Candidate, QTORIN™ Pitavastatin, for the Treatment of Disseminated Superficial Actinic Porokeratosis (DSAP), a Rare, Chronic, and Pre-Cancerous Genetic Skin Disease with No FDA-Approved Therapies

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November 4, 2025 · 7:30 AM UTC

Palvella Therapeutics to Host Third Quarter 2025 Financial Results and Corporate Update Conference Call on November 11, 2025

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October 13, 2025 · 7:30 AM UTC

U.S. Food and Drug Administration Awards Year Two Proceeds from Orphan Products Grant Supporting Palvella Therapeutics' Phase 3 SELVA Trial of QTORIN™ Rapamycin for Microcystic Lymphatic Malformations

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