Applied Therapeutics (APLT) AI Stock Analysis

• Market Cap: $43.24M
• Dividend Yield: N/A
• Average Volume (3M): 2.01M
• Price to Earnings (P/E): ―
• Beta (1Y): 0.38
• Revenue Growth: N/A
• EPS Growth: N/A
• Country: US
• Employees: 35
• Sector: Healthcare
• Sector Strength: 69
• Industry: Biotechnology
• EPS (TTM): 0.52
• Shares Outstanding: 116,356,476
• 10 Day Avg. Volume: 2,705,103
• 30 Day Avg. Volume: 2,006,528
• PEG Ratio: N/A
• Price to Book (P/B): N/A
• Price to Sales (P/S): 6.67
• Price to Cash Flow (P/CF): -0.70
• P/FCF Ratio: 0.00
• Enterprise Value/Market Cap: 26.14
• Enterprise Value/Revenue: N/A
• Enterprise Value/Gross Profit: 2.48K
• Enterprise Value/Ebitda: N/A
• 1Y Price Target: $2.25
• Price Target Upside: 476.92% 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 Trials

The clinical trial in SORD met its co-primary endpoints, suggesting a potentially stronger data package.

Community Support

Govorestat still has a lot of support from the galactosemia KOL community and patient advocates, highlighting the unmet need.

Management Changes

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

Negative Factors

Financial Risks

The company is seen as bearing increased financial risk given its limited cash runway.

Regulatory Challenges

APLT received a Complete Response Letter for govorestat in classic galactosemia, which comes as a major surprise, given the progress the company appeared to be making with the FDA.

Regulatory Delays

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.

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 faces significant financial hurdles characterized by negative revenue, persistent losses, and high leverage. The cash position offers some relief, but the overall financial health is challenged by ongoing operational inefficiencies and cash burn, necessitating strategic changes to achieve sustainable growth.

Income Statement

The company exhibits significant challenges in its income statement. The TTM (Trailing-Twelve-Months) shows negative revenue and a substantial net loss. Revenue growth has been negative, indicating a lack of revenue generation, while profit margins remain deeply negative. The EBIT and EBITDA margins are also unfavorable, reflecting continuous operating losses.

Balance Sheet

The balance sheet reveals high liabilities relative to equity, with a low stockholders' equity position. The debt-to-equity ratio is concerning, indicating financial leverage risk. However, the company maintains a relatively high level of cash and short-term investments compared to its total assets, providing some liquidity buffer.

Cash Flow

Cash flow analysis shows consistent negative operating and free cash flows, indicating cash burn. The operating cash flow to net income ratio suggests inefficiencies in converting income to cash, and the lack of positive free cash flow highlights the company's reliance on financing activities for cash generation.

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

Applied Therapeutics Technical Analysis

• Technical Analysis Sentiment: Neutral
• Last Price: 0.39
• 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 Neutral. The current price of 0.39 is above the 20-day moving average (MA) of 0.37, below the 50-day MA of 0.46, and below the 200-day MA of 3.91, indicating a neutral trend. The MACD of -0.03 indicates Negative momentum. The RSI at 45.94 is Neutral, neither overbought nor oversold. The STOCH value of 73.93 is Neutral, not indicating any strong overbought or oversold conditions. Overall, these indicators collectively point to a Neutral sentiment for APLT.

Applied Therapeutics Peers Comparison

Name	Overall Rating	Market Cap	P/E Ratio	ROE	Dividend Yield	Revenue Growth	EPS Growth
CTMX	62 Neutral	$56.70M	1.80	-58.97%	―	36.45%	―
Sector *	51 Neutral	$5.35B	3.41	-40.83%	2.89%	18.11%	2.60%
AGEN	46 Neutral	$79.47M	―	260.68%	―	-33.81%	23.02%
FBIO	44 Neutral	$49.68M	―	-203.16%	―	-31.76%	86.19%
APLT	39 Underperform	$43.24M	―	-3179.06%	―	―	―
SKYE	38 Underperform	$59.16M	―	-80.48%	―	―	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.