Applied Therapeutics (APLT) AI Stock Analysis

• Market Cap: $64.54M
• Dividend Yield: N/A
• Average Volume (3M): 2.47M
• Price to Earnings (P/E): ―
• Beta (1Y): 1.06
• Revenue Growth: N/A
• EPS Growth: N/A
• Country: US
• Employees: 35
• Sector: Healthcare
• Sector Strength: 43
• Industry: Biotechnology
• EPS (TTM): -0.15
• Shares Outstanding: 141,575,530
• 10 Day Avg. Volume: 2,446,265
• 30 Day Avg. Volume: 2,466,197
• PEG Ratio: -0.08
• Price to Book (P/B): 2.38
• Price to Sales (P/S): 0.00
• P/FCF Ratio: -0.91
• Enterprise Value/Market Cap: 0.58
• Enterprise Value/Revenue: 211.90
• Enterprise Value/Gross Profit: 582.72
• Enterprise Value/Ebitda: -0.10
• 1Y Price Target: $2.25
• Price Target Upside: 411.36% Upside
• Rating Consensus: Moderate Buy
• Number of Analyst Covering: 3

Applied Therapeutics is in the early stages of revenue generation, but significant challenges in achieving profitability and sustaining operations through negative cash flow pose risks. The technical analysis shows downward momentum, and valuation metrics reflect its current unprofitability. Focus remains on operational improvements and expense management to navigate financial instability.

Positive Factors

Clinical Data

The company will present full 12-month data and new top-line 18-month and 24-month data from the INSPIRE registrational Phase III trial of govorestat in sorbitol dehydrogenase (SORD) deficiency at the Peripheral Nerve Society annual meeting.

Management

The strengthening of Applied's management team is a key step in rebuilding the company's reputation and regulatory readiness.

Regulatory Strategy

Management is working with the FDA to determine the data needed to support an appropriate regulatory pathway for approval of govorestat for SORD deficiency.

Negative Factors

Financial Performance

Applied reported a net loss of $21.8 million in the first quarter.

Regulatory Challenges

The recent FDA turnover and uncertainty on the timeline for FDA alignment have led to a push back of the launch of govorestat in galactosemia and SORD deficiency to the third quarter of 2026 in the model.

Stock Performance

The company's stock is expected to continue trading at current levels until there is clarity on when or how either govorestat program will progress toward registration.

Applied Therapeutics Business Overview & Revenue Model

Company Description

Applied Therapeutics (APLT) is a clinical-stage biopharmaceutical company dedicated to developing transformative treatments for patients with high unmet medical needs. The company focuses on novel drug candidates designed to address central nervous system and metabolic disorders. Its core products are centered around small molecules targeting critical pathways involved in disease progression. Applied Therapeutics aims to leverage its scientific expertise to bring innovative therapies from research to commercialization.

How the Company Makes Money

Applied Therapeutics generates revenue primarily through the development and commercialization of its drug candidates. The company invests heavily in clinical trials to bring its products to market, seeking regulatory approvals from agencies like the FDA. Once approved, revenues are expected from product sales and potential partnerships or licensing agreements with larger pharmaceutical companies. These partnerships may provide milestone payments, royalties, or co-development funding. The success of its revenue model is contingent on the successful clinical development and commercialization of its therapies.

Applied Therapeutics Financial Statement Overview

Summary

Applied Therapeutics is beginning to generate revenue, but profitability and cash flow remain significant challenges. The company is reliant on external financing to sustain its operations, which could pose risks if the funding environment tightens. Despite some improvements in financial position, the biotechnology company needs to focus on achieving operational efficiencies and managing expenses to move towards profitability.

Income Statement

Applied Therapeutics has shown a significant increase in total revenue from $0 to $9.993 million in 2023 and to $455,000 in 2024, indicating initial revenue generation in the last two years. However, the company is still reporting substantial net losses, with a negative net profit margin indicating ongoing challenges in achieving profitability. The EBIT and EBITDA margins are deeply negative, reflecting high operating expenses relative to revenue.

Balance Sheet

The company's balance sheet shows a moderate debt-to-equity ratio due to low total debt, but stockholders' equity has been negative in previous periods, indicating financial instability. The equity ratio is relatively low, reflecting a higher proportion of liabilities to assets. While there is an improvement in total assets and stockholders' equity in 2024, the company remains highly leveraged.

Cash Flow

Operating cash flow remains negative, but there is a significant increase in financing cash flow, which suggests reliance on external funding to support operations. Free cash flow remains negative, indicating that the company is not yet generating cash from its operations, which is a concern for long-term sustainability.

Breakdown
TTM	Dec 2024	Dec 2023	Dec 2022	Dec 2021	Dec 2020
Income Statement		Total Revenue
265.00K	455.00K	9.99M	0.00	0.00	0.00
	Gross Profit
64.00K	30.00K	9.64M	-441.00K	-415.00K	-380.00K
	EBIT
-108.73M	-104.30M	-64.53M	-82.95M	-105.62M	-94.47M
	EBITDA
-108.55M	-103.87M	-64.53M	-82.07M	-105.17M	-94.47M
	Net Income Common Stockholders
-43.51M	-105.62M	-119.76M	-81.69M	-104.61M	-93.02M
Balance Sheet		Cash, Cash Equivalents and Short-Term Investments
50.76M	79.40M	49.90M	30.58M	80.82M	96.83M
	Total Assets
56.91M	86.69M	54.83M	38.36M	89.89M	104.51M
	Total Debt
2.70M	2.79M	777.00K	891.00K	1.33M	1.74M
	Net Debt
-48.06M	-76.60M	-49.12M	-15.77M	-52.55M	-55.73M
	Total Liabilities
20.24M	29.68M	71.98M	34.30M	27.35M	22.57M
	Stockholders Equity
36.67M	57.01M	-17.15M	4.06M	62.54M	81.94M
Cash Flow		Free Cash Flow
-94.03M	-84.31M	-55.17M	-78.09M	-90.73M	-78.21M
	Operating Cash Flow
-94.03M	-84.31M	-55.17M	-78.09M	-90.73M	-78.21M
	Investing Cash Flow
0.00	0.00	13.87M	13.17M	12.43M	-19.47M
	Financing Cash Flow
-1.69M	113.81M	74.54M	27.69M	74.72M	136.29M

Applied Therapeutics Technical Analysis

• Technical Analysis Sentiment: Negative
• Last Price: 0.44
• 50DMA: Negative
• 100DMA: Negative
• 200DMA: Negative
• MACD: Negative
• RSI: Neutral
• STOCH: Neutral

Evaluating momentum and price trends is crucial in stock analysis to make informed investment decisions. For APLT, the sentiment is Negative. The current price of 0.44 is above the 20-day moving average (MA) of 0.43, below the 50-day MA of 0.44, and below the 200-day MA of 3.54, indicating a neutral trend. The MACD of 0.02 indicates Negative momentum. The RSI at 49.78 is Neutral, neither overbought nor oversold. The STOCH value of 44.13 is Neutral, not indicating any strong overbought or oversold conditions. Overall, these indicators collectively point to a Negative sentiment for APLT.

Applied Therapeutics Peers Comparison

Name	Overall Rating	Market Cap	P/E Ratio	ROE	Dividend Yield	Revenue Growth	EPS Growth
CTMX	68 Neutral	$335.57M	4.30	-58.97%	―	23.81%	146.45%
Sector *	52 Neutral	$5.19B	3.04	-44.20%	2.82%	16.59%	-0.39%
AGEN	44 Neutral	$103.91M	―	260.68%	―	-38.34%	31.19%
FBIO	41 Neutral	$52.04M	―	-181.84%	―	-32.11%	88.12%
APLT	39 Underperform	$64.54M	―	-83.71%	―	―	―
SKYE	38 Underperform	$66.62M	―	-47.27%	―	―	87.22%

Applied Therapeutics Corporate Events

Applied Therapeutics Faces Leadership Changes and Regulatory Hurdles

Applied Therapeutics, Inc. has appointed John H. Johnson as Executive Chairman and Les Funtleyder as interim CEO, following the resignation of Dr. Shoshana Shendelman. The company is navigating regulatory challenges, having received a Complete Response Letter from the FDA and withdrawing a European MAA for govorestat, while planning to submit a new NDA for Sorbitol Dehydrogenase deficiency after Q1 2025.

Applied Therapeutics Faces FDA Challenges with Govorestat

Applied Therapeutics, Inc. faces challenges with its New Drug Application for govorestat after the FDA issued a warning letter highlighting data capture issues and a dosing error in the AT-007-1002 study. The company has provided detailed records and intends to respond within 15 business days to address these issues. However, forward-looking statements regarding its operations and market prospects involve significant uncertainties, emphasizing the risks and challenges in achieving projected outcomes.