Palvella Therapeutics (PVLA) AI Stock Analysis

• Market Cap: $1.23B
• Dividend Yield: N/A
• Average Volume (3M): 254.47K
• Price to Earnings (P/E): ―
• Beta (1Y): 0.03
• Revenue Growth: N/A
• EPS Growth: N/A
• Country: US
• Employees: 14
• Sector: Healthcare
• Sector Strength: 45
• Industry: Biotechnology
• EPS (TTM): -1.03
• Shares Outstanding: 11,836,490
• 10 Day Avg. Volume: 210,890
• 30 Day Avg. Volume: 254,465
• PEG Ratio: 0.01
• Price to Book (P/B): 0.43
• Price to Sales (P/S): 0.00
• P/FCF Ratio: -2.46
• Enterprise Value/Market Cap: 0.52
• Enterprise Value/Revenue: N/A
• Enterprise Value/Gross Profit: N/A
• Enterprise Value/Ebitda: -33.81
• 1Y Price Target: $181.64
• Price Target Upside: 82.13% Upside
• Rating Consensus: Strong Buy
• Number of Analyst Covering: 15
• EPS Forecast (FY): -3.96
• Revenue Forecast (FY): $28.57K

• Rating: 52 Neutral
• Price Target: $98.00 ▼(-1.73% Downside)

The score is held back primarily by weak financial performance (no recent revenue, ongoing losses, and persistent cash burn), partially offset by a stronger, low-debt balance sheet. Technically, the stock has a constructive longer-term trend with neutral momentum, while valuation remains difficult to assess given a negative P/E and no dividend yield data.

Positive Factors

Late-stage pipeline with first-in-disease potential

A Phase 3 readout that could deliver the first FDA‑approved, first‑line therapy creates durable upside: approval would establish standard‑of‑care positioning in a defined rare disease market, enable commercial infrastructure buildout, and validate the QTORIN platform across additional indications.

Regulatory progress and expedited pathways

Fast Track and engagement around Breakthrough advice materially shorten development timelines and increase regulator dialogue. These designations improve approval probability, reduce time to market, and sustain long‑term program value by lowering regulatory execution risk versus peers without such designations.

Conservative capital structure and runway

A debt‑free balance sheet with material cash reserves provides durable financial flexibility to fund late‑stage trials and regulatory activities without immediate reliance on high‑cost borrowing. This reduces near‑term dilution pressure and supports execution through anticipated 2026–2027 milestones.

Negative Factors

No recent revenue and volatile top line

Absence of recurring commercial revenue undermines self‑funding ability and increases dependence on financing or partnerships. Over a multi‑month horizon, this revenue volatility raises the stakes on clinical outcomes to demonstrate value and achieve sustainable commercial cash flows.

Persistent cash burn and negative operating cash flow

Sustained negative operating and free cash flow creates a structural funding requirement: absent product revenues, the company must raise capital to sustain trials and commercialization. This ongoing burn amplifies financing risk and can force dilution or constrain strategic investments if milestones are delayed.

High dependence on clinical success and external funding

As a clinical‑stage company, long‑term value is binary and tied to trial outcomes and approvals. This concentration risk means negative readouts or regulatory setbacks would markedly impair cash runway and strategic options, making long‑term fundamentals highly contingent on successful execution.

Palvella Therapeutics Business Overview & Revenue Model

Company Description

Palvella Therapeutics, Inc., a clinical-stage biopharmaceutical company, focuses on developing and commercializing novel therapies to treat patients serious and rare genetic skin diseases. Its lead product candidate is QTORIN 3.9% rapamycin anhydrous gel (QTORIN rapamycin) that is in Phase 3 clinical trial for the treatment of microcystic lymphatic malformations, as well as in Phase 2 clinical trial to treat cutaneous venous malformations. It also develops QTORIN rapamycin for the treatment of other mTOR-driven skin diseases. The company is based in Wayne, Pennsylvania.

How the Company Makes Money

Palvella Therapeutics generates revenue primarily through the development and commercialization of its proprietary drug candidates. The company aims to achieve profitability by obtaining regulatory approvals for its therapies and subsequently marketing them to healthcare providers and patients. Revenue streams may include sales of approved drugs, milestone payments, and royalties from licensing agreements. Additionally, strategic partnerships with larger pharmaceutical companies can contribute to earnings by providing funding for research and development, as well as sharing commercialization responsibilities.

Palvella Therapeutics Financial Statement Overview

Summary

Palvella Therapeutics faces substantial financial hurdles, particularly in revenue generation and profitability. Despite a strong equity position and no debt, ongoing losses and negative cash flows pose significant risks. Strategic improvements in operational efficiency and revenue generation are crucial for financial stability.

Income Statement

Palvella Therapeutics has experienced significant challenges on the income statement front. The company reported zero revenue in 2024, down from $42.81M in 2023, leading to a negative revenue growth rate. Gross and net profit margins are not applicable due to the absence of revenue. Consistent negative EBIT and EBITDA margins highlight ongoing operational inefficiencies and challenges in generating profits.

Balance Sheet

The company's balance sheet reveals a solid equity base with zero debt in 2024, improving from previous years. This results in a favorable debt-to-equity ratio. However, despite a high equity ratio and solid cash reserves, the company has a negative return on equity, indicating inefficiencies in using shareholder capital to generate profit.

Cash Flow

Cash flow statements indicate a mixed picture. Free cash flow remains negative, though an increase in financing cash flow suggests reliance on external funding. The operating cash flow to net income ratio is negative, reflecting challenges in converting accounting profits into cash. The lack of free cash flow growth further stresses cash flow issues.

Breakdown	TTM	Dec 2024	Dec 2023	Dec 2022	Dec 2021	Dec 2020
Income Statement
Total Revenue	0.00	0.00	0.00	25.90M	31.42M	29.32M
Gross Profit	0.00	0.00	0.00	23.12M	29.05M	29.32M
EBITDA	-19.11M	-13.12M	18.69M	-30.50M	-43.37M	-34.94M
Net Income	-32.95M	-17.43M	18.69M	-33.28M	-45.74M	-37.23M
Balance Sheet
Total Assets	66.94M	88.23M	7.55M	16.52M	153.56M	105.01M
Cash, Cash Equivalents and Short-Term Investments	63.57M	83.60M	7.35M	16.05M	117.76M	70.44M
Total Debt	0.00	0.00	0.00	0.00	14.89M	16.96M
Total Liabilities	28.25M	25.63M	11.43M	39.70M	102.81M	73.98M
Stockholders Equity	38.68M	62.61M	-3.88M	-23.17M	50.76M	31.03M
Cash Flow
Free Cash Flow	-17.59M	-10.84M	-13.70M	-14.84M	-8.61M	-48.62M
Operating Cash Flow	-17.59M	-10.84M	-13.70M	-14.84M	-7.66M	-45.90M
Investing Cash Flow	0.00	0.00	0.00	0.00	-949.00K	39.21M
Financing Cash Flow	73.93M	87.09M	5.00M	9.57M	59.13M	10.12M

Palvella Therapeutics Technical Analysis

• Technical Analysis Sentiment: Positive
• Last Price: 99.73
• 50DMA: Positive
• 100DMA: Positive
• 200DMA: Positive
• MACD: Positive
• RSI: Neutral
• STOCH: Negative

Evaluating momentum and price trends is crucial in stock analysis to make informed investment decisions. For PVLA, the sentiment is Positive. The current price of 99.73 is below the 20-day moving average (MA) of 100.16, above the 50-day MA of 94.50, and above the 200-day MA of 54.14, indicating a neutral trend. The MACD of 1.89 indicates Positive momentum. The RSI at 51.40 is Neutral, neither overbought nor oversold. The STOCH value of 86.89 is Negative, not indicating any strong overbought or oversold conditions. Overall, these indicators collectively point to a Positive sentiment for PVLA.

Palvella Therapeutics Peers Comparison

Name	Overall Rating	Market Cap	P/E Ratio	ROE	Dividend Yield	Revenue Growth	EPS Growth
TBPH	67 Neutral	$1.02B	35.57	14.03%	―	27.12%	―
TERN	61 Neutral	$3.93B	-35.47	-29.12%	―	―	12.45%
TYRA	57 Neutral	$1.55B	-15.31	-34.75%	―	―	-17.01%
NRIX	54 Neutral	$1.91B	-6.48	-65.35%	―	48.32%	-1.91%
MNPR	53 Neutral	$461.57M	-20.36	-26.54%	―	―	-73.48%
PVLA	52 Neutral	$1.23B	-7.91	―	―	―	―
Sector *	51 Neutral	$7.86B	-0.30	-43.30%	2.27%	22.53%	-2.21%

Palvella Therapeutics Corporate Events

Palvella Highlights QTORIN Pipeline and 2026 Growth Outlook

On January 12, 2026, Palvella Therapeutics posted a new corporate presentation outlining the advancement of its late‑stage pipeline, led by QTORIN 3.9% rapamycin anhydrous gel, which it positions as a potential first FDA‑approved, first‑line standard‑of‑care therapy for microcystic lymphatic malformations and cutaneous venous malformations, collectively representing more than 100,000 diagnosed U.S. patients and an estimated $1‑$3 billion‑plus U.S. peak sales opportunity. The company highlighted that 2025 milestones, including positive Phase 2 data in cutaneous venous malformations in December 2025 and full enrollment of the Phase 3 SELVA trial in microcystic lymphatic malformations, have set up a catalyst‑rich 2026, with topline Phase 3 data in March 2026, a targeted U.S. approval in 2027, new QTORIN rapamycin and QTORIN pitavastatin programs, and multiple planned Phase 2 and Phase 3 trials supporting its longer‑term vision of building an enduring rare disease franchise with 10 or more first‑in‑disease therapies in late‑stage development or on the market.

The most recent analyst rating on (PVLA) stock is a Buy with a $150.00 price target. To see the full list of analyst forecasts on Palvella Therapeutics stock, see the PVLA Stock Forecast page.

Palvella Therapeutics Reports Positive Phase 2 Study Results

On December 15, 2025, Palvella Therapeutics announced positive topline results from their Phase 2 TOIVA study of QTORIN™ 3.9% rapamycin anhydrous gel for treating cutaneous venous malformations. The study achieved statistical significance on multiple efficacy endpoints, with 73% of participants showing improvement. These results could impact the company’s operations by advancing discussions with the FDA for Breakthrough Therapy Designation and a Phase 3 pivotal study, potentially positioning Palvella as a leader in addressing this unmet medical need.

The most recent analyst rating on (PVLA) stock is a Buy with a $200.00 price target. To see the full list of analyst forecasts on Palvella Therapeutics stock, see the PVLA Stock Forecast page.

Palvella Therapeutics Reports Q3 2025 Financial Results

Palvella Therapeutics reported its third quarter 2025 financial results and provided a corporate update, highlighting the progress in its rare disease pipeline. The company is advancing its QTORIN rapamycin product candidates, with significant upcoming milestones including the Phase 2 TOIVA trial results for cutaneous venous malformations expected in mid-December 2025 and Phase 3 SELVA trial results for microcystic lymphatic malformations anticipated in the first quarter of 2026. Additionally, Palvella announced the development of QTORIN pitavastatin for disseminated superficial actinic porokeratosis, with a Phase 2 study planned for the second half of 2026. The company also reported cash reserves of $63.6 million as of September 30, 2025, expected to fund operations into the second half of 2027.

The most recent analyst rating on (PVLA) stock is a Buy with a $105.00 price target. To see the full list of analyst forecasts on Palvella Therapeutics stock, see the PVLA Stock Forecast page.

Palvella Therapeutics Unveils QTORIN™ Pitavastatin for DSAP

On November 5, 2025, Palvella Therapeutics announced a new product candidate, QTORIN™ pitavastatin, designed to treat disseminated superficial actinic porokeratosis (DSAP). This announcement marks a significant step as it aims to introduce the first pathogenesis-directed therapy for DSAP, potentially impacting the company’s market position by addressing an unmet medical need for over 50,000 patients in the U.S. The development of QTORIN Pitavastatin is part of Palvella’s broader strategy to innovate in the field of rare dermatological conditions, which could enhance its standing among stakeholders and within the industry.

The most recent analyst rating on (PVLA) stock is a Buy with a $90.00 price target. To see the full list of analyst forecasts on Palvella Therapeutics stock, see the PVLA Stock Forecast page.