Palvella Therapeutics (PVLA) AI Stock Analysis

• Market Cap: $279.77M
• Dividend Yield: N/A
• Average Volume (3M): 96.91K
• Price to Earnings (P/E): ―
• Beta (1Y): 0.24
• Revenue Growth: -97.15%
• EPS Growth: 54.85%
• Country: US
• Employees: 14
• Sector: Healthcare
• Sector Strength: 69
• Industry: Biotechnology
• EPS (TTM): -12.61
• Shares Outstanding: 11,018,747
• 10 Day Avg. Volume: 92,026
• 30 Day Avg. Volume: 96,908
• PEG Ratio: N/A
• Price to Book (P/B): N/A
• Price to Sales (P/S): 42.95
• Price to Cash Flow (P/CF): 63.60
• P/FCF Ratio: 63.60
• Enterprise Value/Market Cap: >-0.01
• Enterprise Value/Revenue: N/A
• Enterprise Value/Gross Profit: -0.02
• Enterprise Value/Ebitda: N/A
• 1Y Price Target: $49.33
• Price Target Upside: 94.29% Upside
• Rating Consensus: Strong Buy
• Number of Analyst Covering: 9

Palvella Therapeutics' overall score reflects significant financial challenges, particularly in revenue and profitability, which are partially offset by a robust cash position and no debt. Positive corporate developments, such as clinical advancements and strategic financing, provide potential growth opportunities. However, valuation concerns due to negative earnings and the absence of dividends weigh on the score.

Positive Factors

Pipeline Progress

Progress in the company's pipeline remains on track, with significant data expected in the upcoming years.

Regulatory Support

The FDA has shown preliminary support for the SELVA trial design due to overwhelming natural history data supporting no spontaneous remission.

Target Price Increase

The target price for Palvella Therapeutics, Inc. has been increased from $39 to $53.

Negative Factors

Financial Performance

PVLA reported a FY24 net loss of approximately $17.4M and LPS of $7.83.

Financial Runway

Management estimates current cash should provide runway into 2H27 and cover the QTORIN rapa full Ph3 SELVA MLM trial, full Ph2 TOIVA CVM trial, MLM NDA submission, and clinical trial initiations for a new QTORIN rapa indication and a new QTORIN product candidate.

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 is facing financial challenges characterized by diminishing revenues, substantial losses, and negative cash flows. While the company has no debt, which reduces leverage risk, the lack of profitability and cash flow generation poses significant risks. Their financial performance needs improvement to ensure long-term viability.

Income Statement

Palvella Therapeutics shows weak financial health with consistent net losses and declining revenues. The TTM gross profit margin is negative, indicating costs exceed revenues. Additionally, the net profit margin remains negative, reflecting ongoing losses. Revenues have drastically decreased from $42.81M in 2023 to $1.35M in TTM, highlighting significant revenue shrinkage.

Balance Sheet

The balance sheet reflects a relatively stable capital structure with no debt, as the Debt-to-Equity ratio is zero, denoting no leverage risk. However, the Return on Equity is negative due to persistent losses. The equity ratio shows a healthy proportion of equity to total assets but has been decreasing over time, indicating weakening financial structure.

Cash Flow

Palvella Therapeutics has negative free cash flow and operating cash flow, indicative of cash burn in operations without sufficient cash inflows. Although the operating cash flow to net income ratio is negative, it aligns with their negative net income. There is no growth in free cash flows, which is concerning for sustainability.

Breakdown
Dec 2023	Dec 2022	Dec 2021	Dec 2020	Dec 2019
Income Statement		Total Revenue
―	―	―	―	―
	Gross Profit
42.32M	25.47M	31.42M	29.32M	―
	EBIT
-16.33M	-43.91M	-51.83M	-33.92M	-27.16M
	EBITDA
-22.64M	-32.52M	-46.96M	-34.94M	-26.12M
	Net Income Common Stockholders
-24.54M	-33.28M	-45.74M	-37.20M	-25.47M
Balance Sheet		Cash, Cash Equivalents and Short-Term Investments
―	―	―	―	―
	Total Assets
38.68M	95.49M	153.56M	105.01M	141.10M
	Total Debt
0.00	13.10M	13.84M	15.93M	16.22M
	Net Debt
-26.37M	-46.07M	-103.92M	-54.50M	-87.94M
	Total Liabilities
11.92M	67.56M	102.81M	73.98M	89.75M
	Stockholders Equity
―	―	―	―	―
Cash Flow		Free Cash Flow
-53.99M	-60.97M	-8.61M	-48.62M	-54.93M
	Operating Cash Flow
-53.82M	-59.93M	-7.66M	-45.90M	-52.47M
	Investing Cash Flow
―	―	―	―	―
	Financing Cash Flow
―	―	―	―	―

Palvella Therapeutics Technical Analysis

• Technical Analysis Sentiment: Positive
• Last Price: 25.39
• 50DMA: Positive
• 100DMA: Positive
• 200DMA: Positive
• MACD: Negative
• RSI: Neutral
• STOCH: Neutral

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 25.39 is above the 20-day moving average (MA) of 24.30, above the 50-day MA of 23.99, and above the 200-day MA of 17.38, indicating a bullish trend. The MACD of 0.42 indicates Negative momentum. The RSI at 53.26 is Neutral, neither overbought nor oversold. The STOCH value of 67.26 is Neutral, 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
PVLA	52 Neutral	$279.77M	―	-68.21%	―	-97.15%	54.85%
Sector *	51 Neutral	$5.32B	3.41	-40.36%	2.89%	17.93%	2.52%
VNDA	48 Neutral	$247.84M	―	-3.49%	―	3.18%	-835.29%
HUMA	45 Neutral	$223.37M	―	239.90%	―	―	-17.92%
VSTM	44 Neutral	$386.17M	―	-526.33%	―	―	14.39%
XOMA	43 Neutral	$288.54M	―	-16.20%	―	498.72%	49.92%
CADL	33 Underperform	$235.23M	―	-139.56%	―	―	-33.79%

Palvella Therapeutics Corporate Events

Palvella Therapeutics Reports 2024 Financial Results and Updates

On March 31, 2025, Palvella Therapeutics reported its full year 2024 financial results and provided a corporate update, highlighting significant advancements in its clinical programs. The company completed a merger and private placement in December 2024, which facilitated the progression of its QTORIN™ rapamycin into Phase 3 and Phase 2 trials for microcystic lymphatic malformations and cutaneous venous malformations, respectively. These trials could potentially lead to the first FDA-approved therapies for these conditions. Palvella’s financial position, with over $83 million in cash as of December 31, 2024, is expected to support operations into the second half of 2027. The company also announced plans to expand its QTORIN™ platform in 2025, aiming to address additional rare genetic skin diseases.

Palvella Therapeutics Enhances Investor Relations with New Presentation

On March 4, 2025, Palvella Therapeutics, Inc. published a corporate presentation on its website, which will be utilized by company representatives in investor meetings. This strategic move aims to enhance investor relations and provide stakeholders with updated insights into the company’s operations and future prospects.