Palvella Therapeutics (PVLA) AI Stock Analysis

• Market Cap: $289.99M
• Dividend Yield: N/A
• Average Volume (3M): 59.68K
• Price to Earnings (P/E): ―
• Beta (1Y): 0.13
• Revenue Growth: -97.15%
• EPS Growth: 54.85%
• Country: US
• Employees: 14
• Sector: Healthcare
• Sector Strength: 44
• Industry: Biotechnology
• EPS (TTM): -0.74
• Shares Outstanding: 11,055,665
• 10 Day Avg. Volume: 82,457
• 30 Day Avg. Volume: 59,684
• 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: -0.20
• Enterprise Value/Revenue: -0.35
• Enterprise Value/Gross Profit: -1.63
• Enterprise Value/Ebitda: 1.34
• 1Y Price Target: $49.22
• Price Target Upside: 94.39% Upside
• Rating Consensus: Strong Buy
• Number of Analyst Covering: 9

• Rating: 52 Neutral
• Price Target: ―

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

Clinical Trials

The Phase 3 SELVA trial has exceeded the enrollment target of 40 patients, demonstrating a strong interest in the program by the community.

Financial Performance

The company has $75.6M cash which provides runway through the second half of 2027, covering multiple trials and product developments.

Product Development

QTORIN rapamycin was exclusively developed for a serious rare disease where nothing has been approved for nearly 44K diagnosed microcystic LM patients.

Negative Factors

Financial Results

PVLA reported a net loss of approximately $8.2M and an increase in R&D and G&A expenses.

Market Challenges

Current formulations of sirolimus might not be suitable for long-term application due to chemical instability, poor solubility, and molecular weight, which presents challenges for commercial availability.

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
40.87M	0.00	0.00	0.00	31.42M	29.32M
	Gross Profit
34.96M	0.00	0.00	0.00	29.05M	-17.21M
	EBIT
-16.98M	-14.10M	-11.87M	-18.04M	-51.83M	-33.92M
	EBITDA
2.21M	-13.12M	18.69M	-18.04M	-43.37M	-31.61M
	Net Income Common Stockholders
-13.90M	-17.43M	18.69M	-27.55M	-43.37M	-37.23M
Balance Sheet		Cash, Cash Equivalents and Short-Term Investments
6.25M	83.60M	7.35M	16.05M	117.76M	70.44M
	Total Assets
6.39M	88.23M	7.55M	16.52M	153.56M	105.01M
	Total Debt
0.00	0.00	0.00	0.00	13.84M	16.96M
	Net Debt
-6.25M	-83.60M	-7.35M	-16.05M	-103.92M	-53.47M
	Total Liabilities
12.66M	25.63M	11.43M	39.70M	102.81M	73.98M
	Stockholders Equity
-6.27M	62.61M	-3.88M	-23.17M	50.76M	31.03M
Cash Flow		Free Cash Flow
-44.05M	-10.84M	-13.70M	-14.84M	-8.61M	-48.62M
	Operating Cash Flow
-43.92M	-10.84M	-13.70M	-14.84M	-7.66M	-45.90M
	Investing Cash Flow
99.00K	0.00	0.00	0.00	-949.00K	39.21M
	Financing Cash Flow
19.80M	87.09M	5.00M	9.57M	59.13M	10.12M

Palvella Therapeutics Technical Analysis

• Technical Analysis Sentiment: Positive
• Last Price: 25.32
• 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 25.32 is above the 20-day moving average (MA) of 24.04, above the 50-day MA of 23.76, and above the 200-day MA of 19.01, indicating a bullish trend. The MACD of 0.67 indicates Negative momentum. The RSI at 58.82 is Neutral, neither overbought nor oversold. The STOCH value of 72.62 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
Sector *	54 Neutral	$5.38B	3.40	-45.06%	3.28%	16.75%	-0.02%
PVLA	52 Neutral	$289.99M	―	-68.21%	―	-97.15%	54.85%
XOMA	52 Neutral	$299.17M	―	-3.42%	―	638.41%	71.89%
VNDA	48 Neutral	$274.63M	―	-8.38%	―	3.18%	-835.29%
VSTM	44 Neutral	$336.29M	―	-2159.50%	―	―	14.39%
HUMA	42 Neutral	$414.17M	―	-257.38%	―	―	-17.92%
CADL	33 Underperform	$293.10M	―	-98.14%	―	―	-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.